Regulatory Affairs Specialist

REVA Medical, LLC.; San Diego (CA); On-site; USD 95,000 - 125,000; Full time

Job summary

REVA Medical, LLC is seeking a Regulatory Affairs Specialist in San Diego, CA to lead regulatory strategy for complex medical devices, coordinate global filings, and ensure compliance with US CFR, ISO 13485, MDD/MDR, CMDR and MDSAP.

You will work under the VP Quality & Regulatory Affairs, serve as a regulatory point person across disciplines, lead a team of regulatory specialists, and partner with product development and manufacturing to bring devices to market.

Qualifications

• BS degree in a relevant field.
• BS/MS/PhD in engineering or science preferred.

Responsibilities

• Preparing comprehensive regulatory strategies for complex new devices and significant post market changes (e.g. product overhaul/refresh, significant line extension, expanded indications).
• 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 (eg FDA, Notified Bodies, etc.) on regulatory filings at the reviewer or management level.
• 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.

Skills

Regulatory expert

Team leadership

Presentation skills

Regulatory strategy

Cross-functional collaboration

Communication skills

Education

BS degree in a relevant field

BS/MS/PhD in engineering or science preferred

Job description

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

• 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

Salary: $95000 - $125000 per year