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Lead Regulatory Affairs Consultant
2 months ago
Position Summary: The individual in this role will be accountable for the preparation and upkeep of US 510k submissions and EU IVDR Technical Files, ensuring adherence to relevant Corporate and Divisional Policies and quality system protocols.
Key Responsibilities:
- Compile, prepare, and evaluate regulatory submissions for both US and EU markets.
- Proactively identify regulatory challenges and emerging concerns throughout the product submission process, collaborating with regulatory and related teams to devise effective solutions.
- Offer regulatory insights for designated countries/regions in relation to product lifecycle management.
- Track applications under regulatory scrutiny and relay progress updates to internal stakeholders.
- Oversee and submit necessary reports, ensuring timely responses to regulatory bodies.
- Leverage technical regulatory expertise to formulate strategies addressing complex regulatory issues.
- Recognize and assess emerging regulatory matters for the assigned countries/regions.
- Evaluate the adequacy of quality, preclinical, and clinical documentation for submission purposes.
- Provide assessments on registration impacts for design modifications in the responsible countries/regions.
- Deliver strategic advice and technical support regarding regulatory requirements to development teams.
- Ensure that external communications for regulatory objectives comply with established regulations.
Leadership Responsibilities:
The individual will provide guidance without direct authority, acting as a project leader and offering direction to both exempt and non-exempt personnel who operate with significant independence in their roles.
Accountability and Scope:
Individuals will execute and manage technical and scientific regulatory functions for the assigned countries/regions. The role requires independent handling of regulatory submissions with minimal oversight, ensuring that deadlines are consistently met. Effective communication, preparation, and negotiation with various regulatory agencies are essential. The individual must accurately interpret and apply regulatory requirements.
Work will be conducted with a degree of autonomy, allowing for flexibility in determining the technical objectives of assignments. Completed work will be evaluated from a long-term perspective to ensure desired outcomes. The individual will be recognized as an expert and resource in the field of regulatory affairs.
Qualifications:
Education: A Bachelor's Degree in a scientific discipline (such as Biology, Chemistry, Microbiology, Immunology, Medical Technology, Pharmacy, or Pharmacology) is preferred. An M.S. in a technical field is advantageous. Relevant certification (e.g., RAC from the Regulatory Affairs Professionals Society) is a plus.
Experience: A minimum of 5 years of experience in a regulated industry, such as medical devices or pharmaceuticals, is required. Preferred candidates will have hands-on experience with US 510k submissions or EU MDR/IVDR technical files, as well as practical experience in in vitro diagnostics medical devices. Experience leading cross-functional teams on regulatory and compliance projects is also desirable.
