Sr. Regulatory Affairs Specialist - San Diego - PMA Submissions

This San Diego based company manufactures class III implantable medical devices that will help millions of people with a common disease. The company has a history of successful PMA submissions to the FDA, and the team is outgoing and energetic. A great chance for canddiates who want a small company feel but big company resources and stability.

We are looking for candidates who have PMA submissions experience, and have been invovled in regulatory affairs for at least three years. Bachelors degree is preferred and Masters degree loved.

Position Responsibilities

* Ability to communicate effectively with senior management and regulatory agencies in a manner that supports approval and other key company goals/objectives.
* Strong working relationship with regulatory agencies, geography RA specialist and other functions.
* Strong regulatory knowledge in pre- and post-market submissions, products, and geography regulations.
* Plays a leadership role in effectively planning and driving successful completion of complex projects.
* Participates in development of strategies that leverage opportunities and experiences across functions. Influence and inspire alignment with business goals, internally and externally. Review and approve Document Change Orders (COs) for regulatory department.
* Maintain technical knowledge of devices in area of responsibility.
* Solid understanding of product lines/disease states and customers.
* Solid understanding of product distribution release processes and geography launch/maintenance requirements.
* Participate in department systems development initiatives.
* Work with Regulatory Affairs staff, engineers, and technical experts to resolve questions and issues of moderate and high scope and complexity.
* Solid understanding of RA's role and responsibilities within the full quality system and cross-functional roles in the PDP.
* Effectively communicate project plans, status and resource requirements to both core teams and senior management.
* Mentor and teach less experienced Regulatory Affairs Specialists.
To find out more about Real please visit www.realstaffing.com