
Senior Regulatory Compliance Specialist
8 hours ago
Regulatory Affairs Professionals drive the success of our company by ensuring compliance with pharmaceutical and medical device regulations.
Key responsibilities include:
- Developing and implementing regulatory strategies to support new product development and lifecycle management
- Reviewing and submitting regulatory filings, including IND, NDA, ANDA, DMF, 510(k), PMA, CE Technical Files, and related applications
- Collaborating with cross-functional teams to ensure regulatory requirements are integrated into product development
- Managing regulatory documentation archives and maintaining compliance records for audits and inspections
Required qualifications include:
- Strong background in regulatory submissions, product lifecycle management, and cross-functional collaboration
- Excellent communication and problem-solving skills
- Ability to work effectively in a team environment
Benefits include:
- Opportunity to work on challenging projects
- Collaborative and dynamic work environment
- Professional development opportunities
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