Description
Senior Manager of RegulatoryThe Senior Regulatory Affairs Manager will manage the regulatory activities to ensure all products comply and are approved by global regulatory agencies. This will include both domestic and international filings for medical devices.
Core Responsibilities
- Represent Regulatory affairs on project teams, providing advice and support to ensure compliance with regulatory requirements
- Manage regulatory projects, including domestic and international submissions for both medical devices and biologic products
- Manages and develops regulatory strategies and plans to for timely approval of new products
- Develop and implement regulatory strategies for new and existing products to comply with global regulatory agencies for timely approval
- Review labelling and advertising and promotional materials for compliance
- Prepare and manage submissions and correspondence to FDA
- Prepare and manage submissions and correspondence to international regulatory authorities in adherence to regulations and standards
- Manages filing and submissions of 510(k), PMA and/or International registrations
Qualification
- BS or BA (life sciences preferred)
- 6+ years experience in Regulatory Affairs in the medical device sector
- Exceptional problem solving skills and ability to deal with changing priorities.
- Excellent project management skills and analytical capability
- Strong communication skills (written and verbal)
To find out more about Real please visit www.realstaffing.com