Compliance Manager leading compliance initiatives at Medisca, a global healthcare solutions provider. Ensuring regulatory adherence and overseeing vendor programs across multiple jurisdictions.
About the role
- Senior Principal Regulatory Affairs Specialist at Medtronic leading regulatory strategies for Class II robotic devices. Responsible for compliance with US and EU regulations and product lifecycle support.
Responsibilities
- Develop and support global regulatory strategies for Class II devices and accessories for robotic surgical application.
- Be an active member of the product development core teams and responsible for identifying submission deliverables, timelines, and strategic direction.
- Reviews and approves technical documentation.
- Provide feedback and work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies and provide ongoing support to product development teams to assure timely resolution to regulatory issues and questions.
- Prepare FDA IDE submissions, DeNovo/510(k) submissions, or EU submissions for new products and product changes as required.
- Directly communicates with regulatory authorities to resolve questions/issues that arise prior to and during product submissions or other pertinent issues.
- Participate in the product change assessments and define the regulatory impact of product changes in global markets.
- Provide support to market released products as necessary. This includes reviewing labeling, product changes, and documentation for changes requiring regulatory approval.
- Keeps abreast of new and changing global regulatory requirements and keep the business informed of implications of changes.
- Collaborate with International regulatory teams to understand worldwide regulatory requirements to enable the development of strategies and requirements for global commercialization.
- Interact directly with major market regulatory agencies in support of product registration, approval, and commercialization.
- Leads or performs coordination and preparation of document packages for global regulatory submissions, license renewals, internal & external audits and inspections.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Plays an active role in continuous improvement of regulatory processes for the Robotics Business Unit.
Requirements
- Bachelor’s degree required
- Minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.
- Degree in Engineering
- Experience with US and EU submissions (e.g. 510(k), PMA, Pre-Sub, PCCP, IDE, MDR, etc.) with complex medical device systems including hardware, software and artificial intelligence
- Demonstrated ability for strategic thinking, project planning
- Strong influence skills.
- Demonstrated ability to work cooperatively at all levels in an organization to build and maintain relationships required to accomplish program goals
- Ability to balance priorities, work independently or collaboratively to determine and develop solutions
- Excellent verbal/ written communication and presentation skills.
- Demonstrated ability to succinctly and accurately communicate to various cross functional partners.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Director of IT Governance, Risk & Compliance at Zentalis Pharmaceuticals developing GRC strategies. Leading compliance for FDA regulations in a clinical - stage biotech environment.
Licensing Compliance Officer for the City of Hamilton ensuring by - law compliance and conducting inspections. Engaging with the community and liaising with businesses for adherence to regulations.
Regulatory & Compliance Analyst responsible for implementing insurance regulatory filings and compliance. Collaborating with teams to prepare submissions and maintain documentation in a hybrid environment.
Manager of Post Market Compliance overseeing post - market surveillance for global medical device regulations. Engaging with cross - functional teams and maintaining compliance standards in a hybrid role.
IT Risk and Compliance Specialist ensuring security of technology systems for GDIT and its customers. Monitor security posture, assess risks, and implement improvements in security protocols.
Regulatory Affairs Analyst managing regulatory risks and compliance for Pension Insurance Corporation. Working collaboratively to maintain effective regulatory strategies and relationships with UK regulators.
Senior Engineer advising on certification processes for aerospace at Boeing. Engaging in compliance reviews and educational material development across multiple sites.
Chef Formation Conformité supervisant activités de formation conformité dans l’industrie pharmaceutique. Gestion du programme de formation et conformité aux exigences réglementaires.
Responsable de la conformité et des systèmes qualité au sein de Pharmascience sur le site de Candiac. Participation à la gestion des audits internes et des systèmes qualité pour assurer la conformité.