Senior Manager, Regulatory Affairs Operations responsible for regulatory submissions in a biotechnology firm. Overseeing documentation, compliance, and cross - functional collaboration for FDA and EMA submissions.
About the role
- Senior Regulatory Affairs Specialist managing regulatory affairs for Varian Medical Systems. Ensuring compliance with regulatory submissions and collaborating with internal teams.
Responsibilities
- Collaboratively interface with a variety of levels on significant matters, often requiring coordination across organizational units.
- Outline submission and clearance requirements in assigned geographies.
- Develop sound regulatory strategies in alignment with business priorities and update strategies based upon regulatory changes.
- Review and approve R&D, quality, preclinical and clinical documentation for submission filing.
- Compile, prepare, review, and submit high-quality regulatory submissions to authorities on time in US, EU, and Canada.
- Interact and negotiate directly with regulatory authorities during development and review processes to ensure clearance/approvals.
- Evaluate proposed design, clinical, and manufacturing changes for regulatory impact and approve changes in compliance with regulatory requirements.
Requirements
- 5+ years of progressive experience in regulatory affairs, clinical and quality assurance preferably Class II and Class III medical devices.
- Must have experience with pre- and post-market medical device submissions such as 510(k), IDE, PMA, Presubmissions, DeNovos, EU Technical Files, and Design Dossiers.
- Experience in the use of clinical data to support regulatory submissions.
- Experience with international filings (Australia, Japan, China, Latin America etc.) is a plus.
- Strong knowledge of regulations and standards: 21 CFR Part 11/820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, IEC 62366, ISO 10993.
- Educational background: Bachelor’s degree Engineering/ Life Sciences (advanced degree preferred)
- RAC certification (U.S. or EU) is a plus.
Benefits
- medical insurance
- dental insurance
- vision insurance
- 401(k) retirement plan
- life insurance
- long-term and short-term disability insurance
- paid parking/public transportation
- paid time off
- paid sick and safe time
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