CrawlJobs Logo

Senior Regulatory Specialist

imricor.com Logo

Imricor Medical Systems

Location Icon

Location:
United States , Burnsville

Category Icon
Category:
Quality Control

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

100000.00 - 130000.00 USD / Year
Save Job
Save Icon
Apply Position

Job Description:

The Senior Regulatory Specialist is responsible for planning, managing, and implementing regulatory submissions to the EU-notified body, the US FDA, and other country-specific regulatory bodies. This position ensures continued compliance with regulatory agency approvals including change impact reviews. This position is also responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Job Responsibility:

  • Develops domestic and international strategies for regulatory approval of company products
  • Coordinates, compiles, and submits U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country-specific product registrations
  • Develops and maintains positive relationships with regulatory body reviewers through oral and written communications regarding clarification and follow-up of submissions under review
  • Reviews product and manufacturing changes for compliance with applicable regulations and impact on regulatory filings
  • Represents RA on cross-functional product development, manufacturing, and clinical support teams and provides regulatory leadership and feedback throughout the product development cycle. Provides recommendations for how to overcome regulatory barriers
  • Provides technical reviews of supporting documentation for inclusion in regulatory filings
  • Supports Medical Device Reporting (MDRs) and Medical Device Vigilance Reporting
  • Represents RA on other cross-functional projects, which may include process changes and continuous improvement efforts
  • Meets defined goals and objectives through own initiatives, activities, and available resources with minimal supervision
  • Performs other related duties and responsibilities, as assigned

Requirements:

  • Bachelor of Science in a scientific discipline or equivalent education/ training
  • 5+ years’ Regulatory and/or Compliance-related experience in a regulated industry
  • Previous experience with US and EU medical device regulatory requirements including Quality Systems and clinical investigations standards
  • Experience with preparation, submission, and approval for medical devices is required
  • Strong communication skills, both verbal and written
  • Strong analytical and problem-solving skills, as well as a good background in the medical device development process
  • Demonstrated ability to effectively manage multiple projects and priorities
  • Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat

Nice to have:

  • EU MDR transition experience preferred
  • Australian regulations experience preferred
What we offer:
  • Medical
  • Dental
  • Vision
  • Health Savings Accounts
  • Health Care & Dependent Care Flexible Spending Accounts
  • Disability Benefits
  • Life Insurance
  • Retirement Benefits

Additional Information:

Job Posted:
December 09, 2025

Employment Type:
Fulltime
Work Type:
On-site work
Icon
Imricor Medical Systems - All Job Offers
Job Link Share:
Copy Link Icon
Facebook Icon Twitter Icon LinkedIn Icon

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Senior Regulatory Specialist

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist of Cosmo Intelligent Medical Devices.
Location
Location
Italy , Rome
Salary
Salary:
Not provided
cosmoimd.com Logo
Cosmo Intelligent Medical Devices
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in medicine, pharmacology, biomedical science or related scientific discipline, or equivalent
  • Minimum of 5 years of experience in the regulatory affairs field in medical device industry
  • Minimum of 2 years of experience in vigilance reporting according to 21 CFR Part 803 in U.S and to MDD/MDR requirements in EU
  • English proficiency at professional level
  • Deep knowledge and operative understanding of Reg. (EU) 2017/745 and MDCG documents, Title 21 CFR parts 800-898, and technical standards such as ISO 13485, ISO 14971, ISO/TR 20416, ISO 62304
  • Practical understanding of scientific and technological aspects related to software, computer engineering, artificial intelligence, and endoscopy
  • Basic knowledge of Reg. (EU) 2024/1689
  • Strong analytical skills with a detail-oriented approach
  • Ability to work independently and collaboratively across multifunctional teams
  • Highly dynamic and adaptable to a fast-moving and innovative environment
Job Responsibility
Job Responsibility
  • Assess medical device safety by providing input/review to the risk management activities throughout the whole product lifecycle, health hazards evaluations, and clinical evaluation reports
  • Review and provide input on mitigations, labeling and training materials, adverse events, complaints, incidents, and trends
  • Manage and document post-marketing safety data, aggregate complaint data, individual case safety reports, literature reports with safety data, trend analysis
  • Manage vigilance reporting to Competent Authorities and other stakeholders according to country requirements and assess failure investigations from the regulatory viewpoint
  • Work with customers/users to gather information/data to support investigations and complaints management
  • Monitor external sources/trends on emerging issues, including complaints, MDR trends, and regulatory trends, literature and scientific publications
  • Transfer the regulatory compliance aspects during the design and development stage of products and act as contact point across the company functional areas
  • Act as department representative during audits and other regulatory body interactions in the field of vigilance and post-market surveillance
  • Cooperate to the management of documented material and communications with Competent Authorities, Certification Bodies, and other stakeholders according to the given regulatory aspect
  • Cooperate to the management of company regulatory procedures by timely awareness and implementation of changes due to the development in the regulatory landscape
Read More
Arrow Right

Senior Compliance Specialist

The candidate will support the Manager executing the annual compliance audit pla...
Location
Location
Italy , Rome
Salary
Salary:
Not provided
fsi-aegis.com Logo
Aegis FSI
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum five years of relevant experience in a compliance function at a financial intermediary, or in a consultancy firm with a focus on projects for banking groups and financial institutions
  • In-depth knowledge of the legislation governing financial intermediaries regulated by Article 106 of the Italian Banking Law (TUB) and the relevant Bank of Italy Circular 288/2015
  • Fluent English language skills, both written and spoken
  • Solid understanding of the core consumer credit provision processes and the roles of key business and control functions
Job Responsibility
Job Responsibility
  • Analyze regulatory changes, assess their impact on the business, and conduct subsequent gap analyses, providing ongoing consultancy support to business units on all compliance matters
  • Manage the periodic update and review of the compliance risk assessment
  • Lead the review and auditing of compliance within the consumer credit framework, with deep knowledge of specific regulations regarding usury, transparency, POG, conflicts of interest, and data privacy
  • Prepare and update compliance training content, and support the delivery of training courses across the organization
  • Review and update policies and procedures to ensure alignment with current compliance requirements
  • Fulltime
Read More
Arrow Right

Senior Internal Controls Specialist

Our client, a leading consulting organization, is seeking two Senior Internal Co...
Location
Location
Canada , Toronto
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
February 15, 2026
Flip Icon
Requirements
Requirements
  • Undergraduate degree in Accounting, Business Administration, or a related field
  • Professional designation preferred: CIA, CA, CMA, CGA
  • 7+ years of internal/external audit, internal controls, or compliance testing experience
  • Strong knowledge of banking regulations, SOX 404, NI 52-109
  • Understanding of internal control frameworks such as COSO, COBIT, ISO27000 (asset)
  • Familiarity with standards related to service organization reporting (e.g., CSAE 316, SSAE 16, ISA) and CICA requirements for special audit reports
  • Proficiency with Microsoft Suite and Google Suite
Job Responsibility
Job Responsibility
  • Conduct comprehensive compliance testing of internal controls across various business processes
  • Perform detailed walkthroughs, leveraging a strong understanding of control design (including the 5Ws)
  • Assess both design and operating effectiveness of controls
  • Document test procedures, results, findings, and exceptions with precision and clarity
  • Develop and maintain thorough project documentation for management reporting
  • Manage multiple testing projects concurrently while adhering to internal methodologies, timelines, and regulatory requirements
  • Lead and facilitate meetings with business stakeholders to gain process understanding and validate control activities
  • Coach and support junior team members as required
  • Collaborate with cross-functional teams to deliver project objectives and uphold quality standards
What we offer
What we offer
  • 100% remote role with flexibility, aside from occasional client site visits
  • Opportunity to contribute to high-visibility compliance and assurance initiatives
  • Work within an established consulting environment and collaborate with senior stakeholders
  • Engage in meaningful audit, testing, and controls assessment work with enterprise-wide impact
  • Build relationships across multiple business units and enhance your professional portfolio
Read More
Arrow Right

Enterprise Resilience Senior Specialist

As our Enterprise Resilience Senior Analyst, you'll be a seasoned expert leading...
Location
Location
United States , Englewood
Salary
Salary:
41.14 - 61.20 USD / Hour
americannursingcare.com Logo
American Nursing Care
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor's Degree, 4 to 6 years of applicable work related experience may be considered
  • Minimum five (5) years’ experience in Business Continuity, Cyber Resilience, and Disaster Recovery
  • Minimum three (3-5) years leading large-scale crisis and resilience programs and initiatives
Job Responsibility
Job Responsibility
  • Design, manage, and execute a comprehensive training and exercise program (tabletops, drills, functional and full-scale exercises) and lead after-action reviews to validate capabilities, identify gaps, drive remediation, and build system-wide response proficiency
  • Lead the enterprise business continuity program by planning, developing, and managing global risk, intelligence, and business continuity initiatives to ensure system‑level preparedness, response, and recovery capabilities are designed, implemented, and continuously improved
  • Serve as the senior subject matter expert and trusted advisor to executive leadership, clinical and operational leaders, cybersecurity, legal, and communications teams
  • provide guidance before, during, and after incidents and, when needed, act as incident commander, incident manager, or senior advisor to enable timely, coordinated decision-making and recovery
  • Coordinate cross-functional preparedness and resilience efforts across clinical, IT/cybersecurity, facilities, logistics, communications and other stakeholders, and advise on risk mitigation strategies, policies, processes, and technology improvements to reduce disruption impact
  • Establish metrics, reporting, and governance for resilience and business continuity planning
  • prepare briefings for senior leadership and governance committees and track corrective actions to closure to ensure continuous improvement and accountability
  • Maintain external partnerships and regulatory and industry awareness—public health, emergency management, regional healthcare coalitions, law enforcement, and vendors—and ensure all business continuity activities comply with organizational, legal, privacy, and security requirements
What we offer
What we offer
  • medical, prescription drug, dental, vision plans, life insurance, paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually), tuition reimbursement, retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings
  • Fulltime
Read More
Arrow Right

Global Supplier Quality Senior Specialist

The Senior Specialist, Global Supplier Quality is responsible for driving suppli...
Location
Location
Italy , Pomezia; Milano; Bologna; Alanno
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Minimum 7 years’ experience in supplier quality management within pharmaceuticals, medical devices, or food supplements
  • Strong working knowledge of GMP, ISO 13485, HACCP, and global regulatory expectations
  • Demonstrated success in supplier audits, risk-based quality management, and compliance oversight
  • Lead Auditor certification highly desirable
  • Bachelor’s or Master’s degree in Pharmacy, Chemistry, Engineering, or a related technical field
  • Proven experience using digital tools and systems for supplier qualification and performance management
  • Exceptional communication, stakeholder management, and problem-solving skills
  • Ability to operate effectively in a fast-paced, matrixed, and multicultural environment
  • Fluency in English required
  • Strong proficiency with Microsoft Office Suite and other business platforms
Job Responsibility
Job Responsibility
  • Lead global supplier qualification, approval, and requalification processes in alignment with corporate and regulatory standards
  • Develop and maintain comprehensive supplier risk assessments and qualification documentation
  • Oversee the full supplier lifecycle — from onboarding and performance monitoring to periodic reviews and requalification
  • Plan, conduct, and report supplier audits (both on-site and remote) to verify compliance with internal and external standards
  • Ensure adherence to GMP, ISO 13485, HACCP, and other applicable global quality and regulatory frameworks
  • Partner with suppliers to address audit findings, implement corrective and preventive actions, and monitor their effectiveness
  • Support site quality operations in reviewing and approving supplier-provided documentation, including change controls, technical files, and periodic reviews
  • Maintain and update Supplier Quality Agreements, ensuring alignment with internal policies and regulatory requirements
  • Contribute to the preparation and successful execution of regulatory inspections and customer audits related to supplier management
  • Proactively identify and mitigate supplier-related risks impacting product quality or supply continuity
Read More
Arrow Right

Senior Specialist Education

Senior Specialist Education who excels in this role collaborates with nurse mana...
Location
Location
United States , Martinsville
Salary
Salary:
Not provided
coppersprings.com Logo
Copper Springs East
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Current VA RN (or compact state) License
  • Graduate of a professional school of Nursing
  • Master's degree or currently enrolled in Master's in Nursing program required
  • Basic Life Support certification is required
  • Minimum two (2) years of clinical experience in an acute care hospital setting required
  • One (1) year of formal/informal teaching experience preferred
  • One (1) year of management experience preferred
Job Responsibility
Job Responsibility
  • Collaborates with nurse managers and staff to assess the learning needs and competencies of staff
  • Designs, delivers, and assesses learning activities and curriculums related to clinical competencies, departmental/organizational policies, regulatory requirements, and the use of clinical information technologies
  • Serves as a consultant/mentor for staff in areas of program development, clinical practice, and professional development
  • Participates in the development, coordination, and delivery of new staff orientation and education activities
  • Assists in development and implementation of educational programs/learning aids for clinical and non-clinical associates
  • Plans, coordinates, organizes, implements, and evaluates orientation programs, continuing education, and in-services that enhance associate job performance
  • Keeps appropriate educational records
  • Maintains A-V equipment, books, and educational supplies
  • Prepares schedules as needed for educational in-services and coordinates with persons involved
  • Conducts and assists others in orientation, in-services, continuing education, or workshops
What we offer
What we offer
  • Multiple levels of medical, dental and vision coverage
  • Medical plans starting at just $10 per pay period
  • Tailored benefit options for part-time and PRN employees
  • Life, accident, critical illness, hospital indemnity insurance
  • Short- and long-term disability
  • Paid family leave
  • Paid time off
  • Higher education and certification tuition assistance
  • Loan assistance
  • 401(k) retirement package and company match
  • Fulltime
Read More
Arrow Right

Trading Desk Support Senior Specialist

Trading Desk Support Senior Specialist is a critical subject matter expert posit...
Location
Location
Poland , Warsaw
Salary
Salary:
Not provided
https://www.citi.com/ Logo
Citi
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Min. 6 years of relevant experience
  • Proficient English knowledge
  • High stress resistance
  • In-depth knowledge of various capital market products (Equities, Derivatives, Fixed Income, FX, etc.) and their operational lifecycles
  • Consistently demonstrates clear and concise written and verbal communication skills
  • Strong understanding of trade lifecycle processes, including trade capture, confirmation, settlement, and reconciliation
  • Strong communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
Job Responsibility
Job Responsibility
  • Governance of Middle Office activities conducted by 3rd party vendor
  • Monitors trade flows and troubleshoot any trade discrepancies or breaks, liaising with brokers, custodians, and counterparties as necessary
  • Maintain trade support processes and procedures to enhance operational efficiency and mitigate risk
  • Provide training and support to junior team members and assist in their professional development
  • Analyze trade data and generates reports to monitor trade activity, identify trends, and support decision-making processes
  • Stay updated on industry trends, market developments, and regulatory changes impacting trade operations
  • Provide support for trade execution, including trade confirmation, settlement, and reconciliation
  • Monitor trade lifecycle events and ensure trades are processed accurately and in a timely manner
  • Participate in the testing and implementation of trading systems and upgrades or enhancements
  • Investigate and resolve trade discrepancies or breaks with brokers, custodians, and counterparties
What we offer
What we offer
  • Paid Parental Leave Program (maternity and paternity leave)
  • A supportive workplace for professionals returning to the office from childcare leave
  • Award-winning pension plan
  • Multisport
  • Holiday allowance
  • Private Medical Care Program
  • Group Life Insurance
  • Consideration for annual discretionary bonus
  • Employee Assistance Program
  • Access to a wide variety of learning and development programs, online course libraries and upskilling platforms, such as Udemy and Degreed
  • Fulltime
Read More
Arrow Right

Senior Benefits Specialist

The Senior Benefits Specialist is a key member of the Global Capabilities Networ...
Location
Location
United States of America , Tempe
Salary
Salary:
Not provided
https://www.circlek.com Logo
Circle K
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree in HR, Business, or related field preferred
  • 3-5+ years of experience in US employee benefits administration
  • CEBS or CBP certification a plus
  • Equivalent combinations of education and experience will be considered
  • Ability to communicate clearly with others, both written and verbal
  • Able to handle multiple priorities efficiently in a fast-paced setting
  • Experience with Workday and ServiceNow preferred
  • Strong commitment to customer service by problem solving with professionalism and care
  • Willingness to work onsite in Tempe, AZ, five days per week
Job Responsibility
Job Responsibility
  • Handle Tier 3 escalations in Service Now, analyze issues, and resolve them quickly
  • Serve as the contact for the GCN benefits team to address questions and troubleshoot cases efficiently
  • Ensure adherence to benefit policies, regulatory standards, and service-level agreements to promote operational efficiency and precision
  • Routinely analyze ways of working to identify and recommend process improvements, challenge existing methods, and be the champion for the implementation of approved changes
  • Collaborate cross-functionally with internal stakeholders and vendors to resolve issues, mitigate compliance risks, and ensure compliance with service level agreements
  • Manage Workday benefits system updates, including validating requirements, testing, and resolving issues related to changes such as Open Enrollment, data updates, etc.
  • Perform Workday EIB transactions on a regular basis
  • Create and deliver benefits presentations to newly hired employees, ensuring clarity and alignment with policy intent
  • Maintain confidentiality and adhere to all relevant laws and organizational standards, ensuring that all internal documentation and desktop procedures are consistently aligned with these requirements
  • Conduct system audits and detailed reconciliations, including identifying systemic issues and implementing corrective action
  • Fulltime
Read More
Arrow Right
Jobs by Category
Art and Entertainment Jobs Banking Jobs Call Center Jobs Construction Jobs Consulting Jobs Customer Service Jobs Education Jobs Energy Jobs Finance Jobs Gastronomy Jobs Health and Beauty Jobs Hospitality and Tourism Jobs Human Resources Jobs Insurance Jobs IT - Administration Jobs IT - Software Development Jobs Legal Jobs Logistics Jobs Manufacturing Jobs Marketing, Digital Marketing, SEO, SEM Jobs Media Jobs Nursing Jobs Office Administration Jobs Pharmacy Jobs Physical Work Jobs Public Relations Jobs Public Sector Jobs Purchasing Jobs Quality Control Jobs Real Estate Jobs Research and Development Jobs Sales Jobs
Job Positions Jobs by Country
United States Jobs United Kingdom Jobs India Jobs Canada Jobs Australia Jobs Poland Jobs Germany Jobs Ireland Jobs
Company
Blog About Us Contact
Follow Us
Facebook
X (Twitter)
LinkedIn
Instagram
© 2026 CrawlJobs Ltd. All Rights Reserved
Terms & Conditions Privacy Policy