Fantastic medical device company in North County San Diego is currently recruiting for a Director of Regulatory Affairs. Position will report to CEO. This is a terrific opportunity for someone with 10 years in the medical device industry and 5 years managing the regulatory function and submitting 510(k)'s. Position is somewhat person-dependent, and could also be a VP level over Regulatory Affairs and Clinical Affairs.
Major Responsibilities:
Scope: Receives assignments in the form of objectives and establishes goals to reach objectives. Objectives are reviewed by Senior Management to determine success of the position. Involved in developing, modifying and executing company policies that affect regulatory issues and may have a company-wide effect.
Job Complexity: Works on complex problems in which analysis of situations requires an in-depth evaluation of various factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as advisor to colleagues to meet schedules and/or solve problems. Develops and administers budgets, schedules and performance requirements.
Discretion: Erroneous decisions will result in critical delays in schedules and operations and may jeopardize overall business activities.
Interaction: Regularly interfaces with senior management on matters concerning overall company issues. Routinely interfaces with external regulatory entities concerning regulatory status and submissions. Works directly with regulatory consultants, legal counsel, Notified Bodies, Authorized Representatives, FDB and FDA. Requires the ability to change thinking or gain acceptance of others in sensitive situations.
Supervision: Manages through other departments to achieve work requirements. This is a functional manager and may not have subordinates.
Behavior: Must exhibit Company values, practice professional and intellectual integrity, exhibit ethical behaviors and be respectful to others at all times. Must be professional in demeanor and image, deal with differences constructively and be willing to stand up for convictions.
Specific Responsibilities:
1. Provide regulatory support and guidance to project teams and senior management.
2. Prepare and submit FDA and European submissions for approval.
3. Manage process from development of regulatory strategy through to approval.
4. Conduct internal regulatory audits and ensure compliance with all U.S. and international regulatory requirements pertaining to product approval.
5. Maintain relationships and act as liaison with Authorized Representatives, FDA reviewers, Notified Bodies, external regulatory legal counsel and regulatory consultants.
6. Review complaints and lead vigilance and MDR reporting efforts.
7. Review and advise on promotion and advertising materials, labeling, product claims, training materials, publications, press releases or marketing programs to ensure compliance with regulations.
Minimum Requirements – Education, Skills, Experience
1. Minimum BA/BS or equivalent in the Life Sciences, Engineering or related area
2. Must have a complete mastery in the area of responsibility, including relevant standards, practices, and regulations.
3. Must be able to represent own area well, while taking positions and actions based upon a broad view of the company.
4. Must be able to work independently and hands on in a timeline driven startup environment.
5. Must have excellent written and oral communication skills. Requires the ability to write reports and business correspondence.
6. Working knowledge of PC applications such as MS Word, Excel, Project and PowerPoint.
7. 5 years medical device regulatory management experience
8. 10 years medical device or pharmaceutical regulatory affairs experience
9. Must have successfully lead effort to file and receive clearance for a medical device 510(k). Experience with a 510(k) involving clinical trials is a major advantage. Experience in gaining CE Marking is helpful
- Location: Carlsbad, CA
- Compensation: DOE
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