Senior Regulatory Affairs Specialist

Role Overview

• Implementing regulatory strategies, managing regulatory submissions, assessing the regulatory impact of product changes.
• Ensuring high-quality results through mentorship and guidance to team members.
• Collaborating closely with cross-functional partners like R&D, clinical, operations, and marketing.
• Representing the company in discussions with regulatory bodies and industry groups.
• Directing or performing preparation of document packages for regulatory submissions.
• Leading or compiling materials for CE-Mark and FDA submissions, license renewals, and annual registrations.
• Working with engineers and technical experts to develop robust regulatory strategies.
• Recommending changes for labelling, manufacturing, marketing, and clinical protocol reports for regulatory compliance.
• Keeping abreast of regulatory procedures and changes.

Requirements

• Level 8 Honor’s Degree Science or Engineering bachelor's degree/master's with a minimum of 5 years of relevant experience, preferably with Class III Medical Devices.
• A Regulatory Affairs qualification is desirable, but not mandatory.
• Regulatory experience in Medical Devices, Pharmaceuticals or similar regulated industry is required.
• You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
• Strong technical knowledge.
• Experience with FDA regulatory requirements, European Medical Devices Regulation (EU MDR), Regulation (EU) 2017/745 and international regulatory agency requirements.
• Experience with software and hardware medical devices.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)