Senior Regulatory Affairs Specialist

Embark on an enriching journey with PROCEPT BioRobotics, where our vision, mission, and values guide everything we do as a company. At PROCEPT, we put the patient first in everything we do and are committed to revolutionizing treatment for benign prostatic hyperplasia (BPH, otherwise known as prostate gland enlargement) through innovation in surgical robotics. As our company succeeds and grows, we improve the quality of life of patients, provide more effective treatment options for surgeons, uphold the trust of our shareholders. That starts with a commitment to our People with a focus on creating an evolving landscape for your career, brimming with transformative opportunities that provide continuous career growth opportunities.

• Act as a lead regulatory representative on product development teams, communicate regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements
• Develop global regulatory strategies for new and modified products
• Support the monitoring and interpreting of current and new regulatory requirements and international standards for U.S. and Rest of World (RoW)
• Support regulatory effort to comply with new and existing regulations (e.g., FDA Medical Device Regulations, EU-MDR)
• Independently identify and problem solve regulatory and compliance issues, and escalate to senior management as necessary
• Provide effective communication, and quick responses to internal customers
• Drive continuous improvement in internal processes and customer satisfaction
• Identify, develop, and mentor high performing regulatory talent
• Assure that US FDA Quality Management System (QMSR) requirements are followed and executed consistently from RA perspective
• Execute US FDA 510(k) and Technical File creation and remediation, collaborating with cross-functional teams for required content

 

• Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
• 6 years’ experience with a B.S. or 4 years’ experience with a M.S. in regulatory submissions for medical devices
• Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC)
• Ability to work effectively on project teams
• Must be able to manage multiple and competing priorities and manage programs with minimal oversight

• M.S. or Ph.D. in a technical area
• Experience working with both Class II and Class III medical devices.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
• Has a strong attention-to-detail
• Strong written, verbal, presentation, and organizational skills
• Strong analytical and problem-solving skills
• Working knowledge of relevant ISO and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies
• Ability to identify risk areas and escalate issues as appropriate