Overview
Job Title: Senior Regulatory Affairs Specialist
Reports To: Director of Regulatory
Austin Vita is currently supporting a Class III medical device company headquartered in Orange County. In their search for a Regulatory Affairs Professional, this particular client takes employee satisfaction seriously, and offers a variety of accommodations. Join their team and be part of their growth!
ESSENTIAL JOB FUNCTIONS (including but not limited to):
- Take lead on and prepare worldwide regulatory files and regulatory reports as needed for new products and product changes to ensure timely approval for clinical studies and market release, including but not limited to: annual PMA reports, PMA submissions, 510(k), pre-submissions, technical files, change notification and international license renewals.
- Prepare and review regulatory strategies with the leadership team and negotiate submission steps with regulatory bodies, as needed.
- Work with cross-functional teams to assess product changes and possible regulatory impact and serve as external standards and compliance expert.
- Directly communication with the FDA and international regulatory agencies, including but not limited to formal submissions, e-mails and telephone calls with reviewers.
- Maintain and review the Regulatory Standard Operating Procedures, as needed.
- Provide regulatory guidance and evaluation of promotional activities associated with the Company's products worldwide.
- Develop and maintain association with outside organizations and institutions pertinent to the interests and needs of the department and the Company.
- Support both internal and external audits (e.g. FDA).
- Work closely with Research and Development and evaluate proposed changes to product design and development and assess impact of the proposed changes with regard to worldwide approvals and company policies and procedures.
- Lead Complaint/MDR determine meetings and CRB meetings.
- Develop, prepare, analyze and present trend reports for complaints, as required.
- Coordinate cross-functional complaint investigation and analysis with personnel performing failure analysis to gather root cause determinations and properly document complaint closure.
- Review and evaluate complaints, customer feedback and information for quality, accuracy and completeness.
- Prepare and submit complaint trend analysis periodically.
- Provide regulatory inputs to risk management file development and maintenance.
- All other duties and tasks as required and requested by management.
EDUCATION/EXPERIENCE
- Education Bachelor's Degree with experience in the medical device industry; Master's Degree in a technical field preferred
- Experience Minimum 4 years of work experience in medical device industry
- Demonstrated background, understanding and application of U.S. and international regulatory requirements associated with regulatory submissions
- Experience with both pre-market and post-market regulatory standards and submissions
- Experience with complaints processing and handling
- Skills and Abilities Ability to efficiently process, organize and evaluate incoming data to ensure that proper and immediate action is taken
- Strong knowledge of U.S. and international regulations pertaining to regulatory approvals
- Computer literate, including use of Quality Management Systems and MS Office applications
- Ability to work independently
- RAC certification a plus
