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:
- 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
- Preparing global regulatory filings for new products, as well as post-market changes. As necessary, reviews complex regulatory issues with RA manager.
- Providing accurate and consistent regulatory recommendations, decisions, and feedback to product development and manufacturing teams.
- 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.
- Following REVA Quality System procedures to ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR, MDSAP, and all other applicable regulations.
- Maintaining proficiency in worldwide regulatory requirements. Develop general strategies on more effective interactions with government agencies and agency personnel.
- Assisting the RA manager with training and direction of regulatory affairs.
Position Requirements:
- 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
- Excellent oral and written communication skills
- Demonstrated experience in major regulatory filings, e.g. Original PMA, IDE, Design Dossier
- Must have a 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
