Key skills
Project ManagementStakeholder ManagementRisk Management
About this role
Role Overview
- Act as the lead Regulatory Affairs associate on an enterprise-wide strategic initiative to optimize the business’s supply chain
- Support global regulatory strategies for changes related to the initiative
- Conduct global regulatory change assessments and coordinate associated activities for assigned products
- Provide regulatory review of technical reports and documents
- Support risk management activities, vigilance reporting activities, and other quality related initiatives
- Lead regulatory filings as needed for EU/USA, Canada and support ROW
Requirements
- Bachelor’s Degree or higher in a science or engineering discipline AND five (5) years of experience in regulatory affairs in the medical device industry OR High School Diploma/GED AND nine (9) years of experience in regulatory affairs in the medical device industry
- Experience working on combination medical devices with an antimicrobial
- Direct experience authoring regulatory submissions/technical documentation
- Direct experience authoring regulatory strategies and regulatory change assessments
- Experience working and providing regulatory support for new product development teams
- Experience developing regulatory strategies and project management
- Skills include regulatory acumen, cross functional project management, stakeholder management, international submission support, Medical Devices, proficient in Office Suite and Regulatory Management Software
Benefits
- Medical, Dental & Vision
- Health Savings Accounts
- Health Care & Dependent Care Flexible Spending Accounts
- Disability Benefits
- Life Insurance
- Voluntary Benefits
- Paid Absences
- Retirement Benefits