Senior Regulatory Affairs Specialist

About the role

Medtronic seeks a Senior Regulatory Affairs Specialist to lead the coordination and preparation of regulatory document packages across the company. You will work on submissions, license renewals and annual registrations, ensuring compliance with evolving regulations.

Key responsibilities

• Direct and perform coordination of document packages for regulatory submissions, internal audits and inspections.
• Lead compilation of materials required for submissions, license renewal and annual registrations.
• Recommend changes to labeling, manufacturing, marketing and clinical protocols for regulatory compliance.
• Monitor and improve tracking/control systems and stay current with regulatory procedures.
• Interact with regulatory agencies on defined matters and advise on strategies for early clinical trial approvals.

Required profile

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, Quality, Clinical or related field (advanced degree reduces experience requirement).
• 4+ years of professional experience with a bachelor's degree, or 2+ years with an advanced degree.
• Experience in a regulated environment such as medical devices, pharmaceuticals, biotechnology or healthcare manufacturing.
• Ability to interpret technical information, assess risks and make recommendations.
• Strong written and verbal communication skills and proven ability to work independently while managing multiple priorities.

Required skills

• Regulatory submissions preparation
• License renewal processes
• Labeling and manufacturing compliance
• Clinical protocol assessment
• Regulatory agency interaction

What we offer

• Competitive salary range of 115,200 CHF to 172,800 CHF per year.
• Eligibility for Medtronic Incentive Plan (short‑term incentive).
• Flexible benefits package supporting employees at every career and life stage.