Regulatory Affairs Manager
Responsible for leading the Regulatory Affairs department in its efforts to remain in compliance with the FDA regulations; creating and reviewing FDA submission documents, for maintaining Regulatory Affairs files and/or dossiers; and, for other administrative roles/tasks.
Essential Duties and Responsibilities
- Keep up to date in FDA published guidance documents.
- Collaborate with the Corporate RA in the design and review of usability studies to ensure accuracy, validity, and reliability.
- Develop regulatory strategies for new and modified medical devices.
- Prepare, develop, and maintain internal Regulatory informational trackers as well as registration-based databases.
- Collaborate with the Corporate RA in the drafting, editing, and compilation of internal Regulatory Affairs Technical Documentation in support of domestic Regulatory filings and/or registrations.
- Compile and prepare domestic Regulatory license applications that meet specific requirements.
- Maintain domestic product listings and establishment registration details.
- May act as the Regulatory Affairs liaison with internal and external contacts.
- Support and maintain Quality initiatives in accordance with the Quality Policy, and continuously assess ways to improve Quality.
- This position has potential for travel to domestic and international facilities and meetings.
- May perform other duties as assigned
- Manages in order to ensure compliance with all relevant regulatory/legal requirements pertaining the FDA
QUALITY SYSTEMS DUTIES AND RESPONSIBILITIES
- Individual Contributor – Build Quality into all aspects of their work by maintaining compliance to all quality requirements
Education & Experience
- Bachelor’s Level of Degree in the scientific or technical discipline field of study
- Equivalent work-related experience acceptable in lieu of degree
- 5+ years of demonstrated experience in Regulatory Affairs or equivalent knowledge
- Medical industry experience required
- Effective research and analytical skills.
- Ability to work with minimal supervision.
- Knowledge of FDA requirements on usability studies.
- Knowledge of FDA regulations
- Ability to manage several tasks simultaneously.
- Effective technical writing and editing skills.
- Experience in the following computer software applications: Microsoft Office,
- Exceptional interpersonal skills.
- Strong organizational skills.
- Strong communication skills (written and verbal).
- Ability to effectively communicate both internally and externally.
- Ability to read and interpret documents such as safety rules, operating and maintenance, instructions, and procedure manuals. Ability to write routine reports and correspondence.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Exposure to standard office environment
- Ability to frequently lift and/or move up to 15 lbs.
- Ability to occasionally lift and/or move up to 50 lbs.
- Ability to regularly sit or stand for extended periods of time
- This position requires some travel up to 25% of the time
Learn more here
Job posted: 2020-11-19