Staff/Principal Regulatory Affairs Specialist

Job Description

• The Staff/Principal Regulatory Affairs Specialist will function as a subject matter expert and will be part of a high-performing RA team and responsible for contributing to the development of regulatory strategies, preparing U.S. and major market submissions and obtaining approval for the ReCor Medical product portfolio.

Qualifications

• Minimum of a Bachelors’ degree preferably in life sciences and/or biomedical engineering. Advanced degree preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society). • Minimum of 10 years’ experience in regulatory within medical device industry • Minimum of 5 years' experience with CEP, CER, PMCF. • Prior experience with US IDE submissions, CER, PMS, PMCF • Experience/knowledge of MDR requirements and Clinical evaluation requirements. • Must be able to manage multiple and competing priorities and manage programs with minimal oversight. • Experience with medical device hardware and software requirements and software regulations. • Demonstrated ability to work well in dynamic and cross functional team environment. • Demonstrated collaboration and leadership skills in team setting. • Solid understanding of design control and change control. • Experience reviewing design specifications and other technical documents. • Excellent interpersonal and communication skills, both oral and written. • Ability to identify risk areas and escalate issues as appropriate. • Self-motivated with excellent time management skills • Strong team player; willing to work collaboratively.

Benefits

• Manages post market activities, including but not limited to EU MDR and MEDDEV compliant Clinical Evaluation documents for new products and maintain/update existing company Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), and Post Market Clinical Follow Up (PMCF) Plans/Reports, Periodic Safety Update Reports, Post approval study reports in alignment with applicable clinical and regulatory standards and business needs. • Represent regulatory in clinical program teams and communicate regulatory strategies. • Review and approve internal engineering documentation and change orders. • Provide support to currently marketed products as necessary including review of labeling, promotional material, product changes and documentation for changes. • Lead product related regulatory compliance activities, including WEEE, Prop 65, REACH and RoHS. • Develops and implements processes involved with maintaining annual licenses, registrations and listings. Ensures both regulatory compliance needs, and business needs are met. • Lead the development of internal procedures, templates, style guides and departmental continuous improvement initiatives as they relate to the function. • Interprets new or existing regulatory requirements (US, EU, OUS) as they relate to the product portfolio and regulatory and quality system procedures. • Complies with U.S. Food and Drug Administration (FDA), EU and international regulations, other regulatory requirements, company policies, and governing procedures and processes. • Keep abreast of changes in agency regulations and requirements, and trains stakeholders accordingly. • Assist in organizational and planning skills to manage complex regulatory projects within timelines and budgets. • Provide business and product information to international regulatory staff to enable development of strategies and requirements for global commercialization. • Continuously evaluate, recommend, and implement improvements as needed. • Willingness to perform other responsibilities as assigned.