Regulatory Affairs Senior Specialist
4 days ago
We are seeking a highly skilled Regulatory Affairs Senior Specialist to join our team at Arthrex, Inc. in Naples, FL. As a key member of our regulatory affairs team, you will be responsible for managing product activities related to regulatory submissions and registration for our Digital Innovation product lines.
This is a remote position, and you can work from anywhere in the United States. The ideal candidate will have 5+ years of relevant experience in regulatory affairs, preferably in the life science industry. A Bachelor's degree in an engineering or science discipline is required, with an advanced degree preferred.
Key Responsibilities- Develop U.S., EU, and Canada regulatory strategies and implementation plans for new products and review proposed changes for impact on regulatory strategy and status.
- Evaluate the risk of proposed regulatory strategies and offer solutions as applicable.
- Advise and provide regulatory direction to assigned Product Development Teams on regulatory requirements, documentation, and testing needed for FDA, EU MDR, and Health Canada regulatory submissions and registrations.
- Prepare, write, and submit FDA, Notified Body, and Health Canada submissions for new products and product changes as required, in accordance with established timelines and submission dates.
- 5+ years of relevant experience in regulatory affairs, preferably in the life science industry.
- Bachelor's degree in an engineering or science discipline, with an advanced degree preferred.
- Orthopedic medical device experience is preferred.
- Regulatory Affairs Certification (RAC) is preferred.
- Medical, dental, and vision insurance.
- Company-provided life insurance.
- Voluntary life insurance.
- Flexible spending account.
- Supplemental insurance plans (accident, cancer, hospital, critical illness).
- Matching 401(k) retirement plan.
- Annual bonus.
- Wellness incentive program.
- Gym reimbursement program.
- Tuition reimbursement program.
- Trips of a lifetime.
- Paid parental leave.
- Paid time off.
- Volunteer PTO.
- Employee assistance provider.
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