Director/Manager of Regulatory Affairs (HLE0610-01) Baltimore, Maryland
It is time to make that jump in your career! We are working directly with a life sciences company who is looking for a Manager of Regulatory Affairs. This person will develop, maintain, and monitor policies, procedures, practices, and activities to assure compliance to all FDA standards. The position reports to the Senior Vice President (SVP).
Key Functional Responsibilities
- Lead the regulatory clinical efforts, including establishing and maintaining clinical protocols, informed consent, IRB submissions, trial monitoring, data preservation, and record keeping.
- Maintain close liaison with regulatory authorities (domestic and foreign) and clinical, scientific, and manufacturing collaborators on matters that impact the regulatory responsibilities of the company.
- Audit and monitor internal processes and contract facilities for compliance with regulatory requirements, including FDA, CE, and ISO in application to medical devices.
- Participate in the product development process to assure products are designed in compliance with FDA regulations and applicable international quality systems standards.
- Within the management team, propose, develop and implement regulatory policies and strategies.
- Design, develop, and deliver regulatory training to employees.
This is an exciting opportunity for someone to grab on to. They are looking for 3 years of experience and a minimum of a bachelor’s degree in a related field. They are looking to hire immediately so do not miss out!
All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.
GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 29 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.