Regulatory Affairs Specialist

Reva Medical • San Diego, CA

5d

About The Position

The Regulatory Affairs Specialist is a regulatory expert in US, EU, and other regional filings and serves as a key regulatory point person across scientific and technical disciplines, which may include biocompatibility, mechanical testing, preclinical testing, risk management, and CMC. The role independently develops regulatory strategies and resolves regulatory issues, manages priorities across multiple projects, leads teams, and works with product development and manufacturing teams. The position reports to the VP Quality & Regulatory Affairs and is exempt.

Requirements

• Bachelor's degree in a relevant field.
• At least 5 years of medical device experience with a BS degree, along with work experience in regulatory affairs; or at least 4 years with an MS degree; or at least 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/software, documentation, and archives.
• Ability to manage multiple tasks and projects and prioritize effectively.
• Ability to independently identify and initiate tasks and projects aligned with objectives.
• Ability to manage conflict, motivate teammates, and lead teams to completion of objectives.
• Knowledge of the design and conduct of clinical trials.
• Ability to lead business interactions with upper management and regulatory meetings with government entities.

Nice To Haves

• BS, MS, or PhD in engineering or science is preferred.
• Expertise in scientific or technical disciplines such as biocompatibility, mechanical testing, preclinical testing, risk management, or CMC.

Responsibilities

• Prepare comprehensive regulatory strategies for complex new devices and significant post-market changes, such as product overhauls or refreshes, significant line extensions, and expanded indications, and communicate these strategies 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.
• Professionally negotiate and lead meetings, such as Pre-Subs, with government entities including the FDA and Notified Bodies regarding regulatory filings; negotiate significant issues with RA Management.
• Follow REVA Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP, and other applicable regulations.
• Maintain proficiency in worldwide regulatory requirements.
• Develop general strategies for more effective interactions with government agencies and agency 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.
• Manage multiple tasks and projects, set priorities, independently identify and initiate work aligned with objectives, and manage conflict while motivating project teammates.
• Lead business interactions with upper management and present regulatory information effectively.
• Apply knowledge of the design and conduct of clinical trials.

What This Job Offers

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