7 months ago
The Regulatory Affairs – Medical Device Team is looking for a Senior Manager, Regulatory Affairs, Med Device to develop and implement regulatory strategies and processes for medical devices and combination products.
- Responsible for the creation, implementation and maintenance of global regulatory strategies and plans.
- Direct and/or support global filing activities including team reviews prior to submission
- Review and approve device design control deliverables
- Create and support execution and maintenance of regulatory processes
- Direct internal review of policy for global regulatory guidance and regulations
- Identify and communicate relevant guidance, policies, standards, and regulations
- Create and maintain relationships with internal and external stakeholders
- May be required to perform regulatory review of labeling
- Review regulatory sections in development, quality, and supply agreements
- In charge of hiring and mentoring regulatory staff
6-8 years of Regulatory Affairs, Life Sciences, Engineering related experience with appropriate degree
- 5-7 years of experience working on United States and international medical device and/or combination product regulations
- 6-8 years of related experience in the medical device or combination product industry
- 1-3 years of direct managerial and/or leadership experience