Senior Manager/Director Regulatory Affairs

Description

Senior Manager of Regulatory

The 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

- Develop and implement regulatory strategies for new and existing products to comply with global regulatory agencies

- 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

- Manage and prepare submissions for 510k and PMA

Qualification

- BS or BA (life sciences preferred)

- 6+ years experience in Regulatory Affairs in the medical device

- 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