Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Reports To: VP Quality & Regulatory Affairs

Position Status: Exempt

Description:

• Broadly recognized as a Regulatory Expert in US, EU, and other regional Regulatory filings.
• Considered a key regulatory point person in multiple scientific and/or technical disciplines, e.g. biocompatibility, mechanical testing, preclinical testing, risk management, CMC etc.
• Can be trusted by REVA management as an independent regulatory expert on strategy and issue resolution
• Demonstrated ability to handle multiple tasks/projects and manage priorities accordingly
• Demonstrated ability to independently identify and initiate tasks/projects in line with objectives
• Demonstrated ability to manage conflict with and motivate teammates on project teams
• Demonstrated ability to lead a team to completion of objectives
• Knowledgeable in design and conduct of clinical trials
• Able to lead a team of Regulatory Specialists on internal department projects
• Strong presentation skills and able to lead business interactions with upper management

Responsibilities: Independent from RA Management, a Regulatory Affairs Specialist V is responsible for:

1. Preparing comprehensive regulatory strategies for complex new devices and significant post market changes (e.g. product overhaul/refresh, significant line extension, expanded indications). Clearly communicates strategies to RA management, core teams, and business unit leadership
2. Preparing global regulatory filings for new products, as well as post-market changes. As necessary, reviews complex regulatory issues with RA manager.
3. Providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
4. Able to professionally negotiate and lead meeting (eg Pre-Subs) directly with government entities (e.g. FDA, Notified Bodies, etc.) on regulatory filings at the reviewer or management (eg Chief or Deputy) level. All significant issues are negotiated with RA Management.
5. Following REVA Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP, and all other applicable regulations.
6. Maintaining proficiency in worldwide regulatory requirements. Develop general strategies on more effective interactions with government agencies and agency personnel.
7. Assisting the RA manager with training and direction of regulatory affairs.

Position Requirements:

1. BS degree in a relevant field

• BS/MS/PhD in engineering or science preferred

• • • 5+ years of medical device experience with BS degree, and work experience in regulatory affairs
    • 4+ years of medical device experience with MS degree, and work experience in regulatory affairs
    • 3+ years of medical device experience with PhD, and work experience in regulatory affairs

1. Excellent oral and written communication skills
2. Demonstrated experience in major regulatory filings, e.g. Original PMA, IDE, Design Dossier
3. Must have a working knowledge of FDA, ISO, QSR, and EU regulations for handling complaints, reporting incidents, and implementing corrective and preventive actions
4. Knowledge of PC hardware/software, documentation and archives