Regulatory Affairs Specialist

Reva Medical LLC • San Diego, CA

3d • $95,000 - $125,000

About The Position

The Regulatory Affairs Specialist is an experienced regulatory expert for US, EU, and other regional filings. The role serves as a key regulatory point person across scientific and technical disciplines, such as biocompatibility, mechanical testing, preclinical testing, risk management, and CMC. The specialist independently develops regulatory strategies, resolves issues, provides recommendations to product development and manufacturing teams, and leads regulatory work with internal teams and government entities. The role also supports training and direction of regulatory affairs staff.

Requirements

• Bachelor’s degree in a relevant field.
• At least 5 years of medical device experience and regulatory affairs work experience with a BS degree; 4 years with an MS degree; or 3 years with a PhD.
• Excellent oral and written communication skills.
• Demonstrated experience in major regulatory filings, such as Original PMA, IDE, or Design Dossier.
• Working knowledge of FDA, ISO, QSR, and EU regulations for handling complaints, reporting incidents, and implementing corrective and preventive actions.
• Knowledge of PC hardware and software, documentation, and archives.
• Demonstrated ability to handle multiple tasks and projects and manage priorities.
• Demonstrated ability to independently identify and initiate tasks and projects in line with objectives.
• Demonstrated ability to manage conflict with and motivate teammates on project teams.
• Strong presentation skills and ability to lead business interactions with upper management.
• Knowledge of the design and conduct of clinical trials.
• Ability to independently serve as a regulatory expert on strategy and issue resolution.

Nice To Haves

• MS or PhD in engineering or science.

Responsibilities

• Prepare comprehensive regulatory strategies for complex new devices and significant post-market changes, and communicate them to RA management, core teams, and business unit leadership.
• Prepare global regulatory filings for new products and post-market changes, consulting the RA manager on complex regulatory issues as necessary.
• Provide accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
• Negotiate and lead meetings, such as Pre-Subs, with government entities including the FDA and Notified Bodies; escalate significant issues to RA Management.
• Follow REVA Quality System procedures to ensure compliance with applicable regulations, including US CFR, ISO 13485, MDD/MDR, CMDR, and MDSAP.
• Maintain proficiency in worldwide regulatory requirements and develop general strategies for more effective interactions with government agencies and personnel.
• Assist the RA manager with training and direction of regulatory affairs.
• Lead teams of Regulatory Specialists on internal department projects and lead teams to completion of objectives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior