Sr. Regulatory Affairs Specialist

LimFlow SA - Research Triangle Park, NC

Full-time - Mid Level

Research Triangle Park, NC

Miscellaneous Manufacturing

About the position

LimFlow is searching for an experienced and highly motivated Sr. Regulatory Affairs Specialist to support Class II and Class III regulatory filings in the United States and select international markets. In this critical position, you will also assist the company in maintaining compliance with quality system regulations ISO 13485 and 21 CFR 820 while also supporting the R&D team with a focus on product development and manufacturing activities and ensuring regulatory compliance on various projects.

Responsibilities

• Creation and updating of regulatory documentation including Investigational Device Exemptions (IDE), Pre-Market Notifications (510k), Pre-Market Approvals (PMA), Establishment Registration, Technical Files, Design Dossiers, and Notice of Changes
• Ensure that product development and product modifications (change control) meet quality and regulatory requirements
• Support day-to-day management of the LimFlow Quality System
• Participate in QMS documentation writing
• Participate in the drafting and reviewing of Test Protocols/Reports with the R&D team
• Participate in the risk management process (dFMEA, risk management plan, risk management report)
• Review non-conformance (CAPA), Documentation Control, Suppliers and Product Release processes
• Assist in implementing strategies for earliest possible approvals of applications
• Ensure timely preparation of organized and scientifically valid applications
• Assist in translating regulatory requirements into practical, workable plans
• Assure that the company complies with applicable global regulatory requirements and standards for the development, pre-clinical and clinical evaluation, manufacturing, and marketing of its products
• Participate in and support the interaction, audits, negotiations, and reporting with regulatory agencies
• Actively participate in or monitor complaint handling and/or vigilance reporting
• Maintain regulatory procedures and documents to maintain approvals and certification for development, manufacturing, and marketing of products
• Inform senior management of regulatory requirements and status of products and significant regulatory issues/trends
• Other duties may be assigned as necessary.

Requirements

• Bachelor's degree and 5+ years of regulatory affairs experience (stent experience preferred)
• Knowledge of the medical device environment, in particular ISO 13485 and 14971:2019 standards, FDA, QSRs, the European Directive 93/42/EC as well as the new Regulation 2017/745/EU
• Excellent interpersonal skills, professional maturity, proactive communication skills, and strong written and verbal communication and presentation skills
• Strong initiative complemented with a sense of accountability, sense of urgency and adaptability
• Proven success and desire to work in a fast-paced work environment
• Ability to work independently and collaboratively as part of a diverse, dynamic interdisciplinary team
• Strong mathematical and statistical abilities
• Proficient with Microsoft Office
• Ability to problem solve and troubleshoot
• Ability to work remotely with up to 25% travel as needed
• Fluent in both written and spoken English (fluency in Spanish and/or French desirable)
• Must have the ability to work in a home based office
• Based in the United States with full work authorization.

Benefits

• Competitive compensation
• Ability to work remotely