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Senior Regulatory Affairs Specialist
- Posted: 15/11/2023
- Salary: $130,000 - $150,000
- Location: Lincoln Park, New Jersey, United States
- Job Type: Permanent/Fixed Term
This is an opportunity for a Senior/Principal Regulatory Affairs Specialist to join a Medical Device organization focused on product development and innovation, transforming healthcare into homecare.
Main Responsibilities
- Support and prepare all regulatory submissions for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance and direction.
- Collaborate with engineering and prepare all regulatory submissions for FDA, Health Canada, Notified Bodies, and other regulatory agencies, with limited guidance and direction.
- Compile and coordinate submission of 510k documents
Experience Required
- Have at least 6+ years of regulatory experience with Medical Devices.
- Deep knowledge new product submissions/510k submissions.
- Strong experience in EU Regulations (Medical Device directives (93/42/EC) and EU MDRs)
- Ability to work onsite near Wayne, NJ 5 days
Callum Sparkes
Director