Senior Regulatory Affairs Specialist

Job description

Job responsibilities

• 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…
• 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

Job requirements

• 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)