Associate Director leading Global Regulatory Affairs and Clinical Safety for pharmaceutical partnerships. Coordinating cross - functional activities to maintain regulatory obligations and compliance.
About the role
- Senior Regulatory Affairs Specialist managing global regulatory activities for powered surgical devices. Supporting compliance efforts across multiple international markets with a focus on U.S. and EU standards.
Responsibilities
- Support currently marketed products by completing sustaining activities, which include but are not limited to, evaluating product changes and labeling changes, reviewing ad promo, and submitting change notifications to regulatory authorities.
- Team with business unit Regulatory Affairs Specialists (RAS) and international regulatory staff to provide regulatory support for changes to existing products.
- Work with RAS, engineers, and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
- Prepare FDA submissions and European Technical Files/Technical Documentation (MDD and MDR) for product changes and/or new products, as required, to ensure timely product launch.
- Prepare submissions and reports for FDA and notified bodies, and support other international agencies as required.
- May interact directly with FDA and notified bodies, and indirectly with international regulatory agencies.
- Maintain proficiency in US and EU regulatory requirements.
- Establish and maintain good relationships with agency personnel.
- Ensure personal understanding of all quality policy/system items that are personally applicable.
- Follow all work/quality procedures to ensure quality system compliance and high-quality work.
- Support post-market regulatory compliance activities for US and EU.
- Keeps abreast of regulatory procedures and changes.
- Develop and maintain regulatory affairs department procedures and implement process improvements.
- Comply with applicable US, EU, and international regulatory laws/regulations/standards and the Code of Conduct.
- Assist in keeping the company informed of US and EU regulatory requirements.
- Directs or performs coordination and preparation of document packages for internal audits and inspections.
- Leads or compiles all materials required for submissions, license renewals, and annual registrations.
- Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking/control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Recommend strategies for earliest possible approvals of clinical trials applications.
Requirements
- Bachelor’s degree required
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
- 4+ years of U.S. and EU regulatory submission experience (510(k) and Technical Documentation)
- Experience with software and electrical regulatory requirements
- Experience with international standards (ISO, GHTF, ICH, IEC)
- Proficient understanding of FDA and MDR requirements
- Knowledge of Medical Device Quality Systems (21 CFR 820, ISO 13483)
- Experience working with cross-functional teams
- Project management skills
- Product development experience
- Knowledge of Medtronic procedures and systems
- Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment.
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
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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