Regulatory Affairs Specialist
Company: Midmark Corporation
Position: Regulatory Affairs Specialist
Location: Torrance, California
Posted: May 2, 2020
Job Type: Fulltime
Contact Name: Sandra Dancy
Email: [email protected]
The Regulatory Affairs Specialist is responsible for implementing the global introduction and continued approval/licensure of new and revised products. They provide subject matter expertise and are responsible for advising and guiding the local organization on regulatory topics. These activities will all be done in full compliance with U.S. and international regulatory requirements.
- Prepare U.S. FDA and Health Canada submissions for new products and product changes
- Advise technical, marketing and sales teammates on regulatory requirements (e.g., Design Controls, CE Marking, IDE, IRB, Labeling, and Promotion).
- Provide guidance and review of product labeling, change control and other related product documentation.
- Assist with regulatory audits from partners and external regulatory agencies
- Maintain the company’s Medical Device Listing and Device Establishment registration forms.
- Interpret new and existing regulatory requirements as they relate to our sector products and initiate actions to assure compliance
- Participate as the regulatory representative on project teams and provide guidance and direction to ensure FDA and international product registration/licensing requirements are addressed and met prior to commercial release
- In collaboration with Regulatory management, lead submission activities for devices in gaining required clearances through the processes of IDE’s, 510(k) s, PMA’s, CE marking.
- Support design verification and validation including usability risk management
EDUCATION and/or EXPERIENCE:
- BA/BS degree in engineering or life sciences
- At least five years of progressive experience in domestic/international regulatory submissions, design control systems and/or regulatory compliance.
- Experience with product registration requirements US, Canada, EU and other major international markets i.e. China, Australia, Brazil, Saudi Arabia, etc.
- Experience in the preparation of 510(k) submissions
- Experience with development and post market support of Class I and II Medical Devices
- This position assures company compliance to all pertinent United States FDA, state, and international regulatory requirements which are applicable to the design, manufacture and distribution of medical and diagnostic devices.
- Knowledge of international quality and product standards for electro-mechanical equipment (e.g. ISO14971, ISO13485, EN60601, IEC62304, etc.)
- Excellent written and oral communication
- Strong project management and organizational skills.
- Excellent verbal and written communication skills.
- Strong analytical and problem-solving skills.