Key skills
CR
About this role
Role Overview
- Provide regulatory affairs domain expertise and influence at all levels in support of the Wound Management device portfolio
- Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications
- Prepare Pre-Sub and 510(k) submissions and technical documents to support CE mark and other international submissions
- Participate in negotiations and interactions with regulatory authorities during the development and review process
- Provide business and product information to the international regulatory affairs team
- Support international product registrations as needed
- Manage multiple projects and prioritize tasks
- Collaborate with engineering, quality, clinical, marketing, and other functions
Requirements
- Bachelor’s degree required
- Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience
- Experience successfully achieving FDA clearance through a 510(k) submission
- Experience interacting directly with the FDA
- Experience managing or contributing to multiple regulatory submissions
- Familiarity with medical device regulatory lifecycle management
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement
- Capital Accumulation Plan (available to Vice Presidents and above)