Key skills
CR
About this role
Role Overview
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of the company, internal audits and inspections
- Leads or compiles all materials required in submissions, license renewal and annual registrations
- Collaborate closely with internal stakeholders including global post market teams to ensure consistent and compliant execution of post-market activities including design changes
- Write, update and maintain technical documentation
- Review promotional material for accuracy and compliance
- Keeps abreast of regulatory procedures and changes
- May direct interaction with regulatory agencies on defined matters
- Recommends strategies for earliest possible approvals of clinical trials applications.
Requirements
- Bachelor’s degree required
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
- Experience in the medical device industry
- Working knowledge of global regulatory frameworks including MDR (Medical Device Regulation)
- Excellent attention to details, proactive approach and ability to work independently
- High learning agility and ability to work under pressure
- Detail-oriented and organized, capable of managing multiple priorities while meeting strict regulatory deadlines.
- 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 (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)