Senior Manager, Regulatory Affairs Job Description Template
Our company is looking for a Senior Manager, Regulatory Affairs to join our team.
Responsibilities:
- Build effective and sustainable cross functional relationships;
- Implement and improve regulatory related QMS procedures;
- Provide guidance and support on interaction with governmental agencies or regulatory bodies (e.g. FDA, CPSC, Notified Bodies, etc.);
- Implement and maintain all regulatory registrations and submissions required for market entry;
- Review and approve all device labeling, IFUs and packaging;
- Support internal/external audits and implement corrective/preventive action as needed;
- Support day to day regulatory and QMS operations;
- Work with Senior Management to develop class I and class II regulatory strategies for current and new market entries (e.g. US, EU, APAC, LATAM, etc.);
- Work with Human Resources, provide comprehensive regulatory training to all employees;
- Work with New Product Quality and Quality Systems to provide guidance and support on Healthcare and Consumer development;
- Create and submit regulatory submissions (e.g. 510k, IDE, Technical Files, etc);
- Support design control process to ensure regulatory documentation is adequate for required submissions;
- Oversee the IRB interaction for any clinical research;
- Motivate, inspire, and improve regulatory compliance culture across the organization;
- Support complaint handling process with regulatory guidance.
Requirements:
- Consumer products (e.g., CPSC);
- Bachelor’s Degree or Equivalent.