Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist is responsible for day‑to‑day regulatory affairs tasks required to maintain compliance with Coloplast’s quality system and applicable regulatory requirements. This role prepares, monitors and communicates regulatory submissions and supports post‑market surveillance, change analysis, claims review and vigilance reporting.

Key responsibilities

• Support compilation of high‑quality regulatory submissions to expedite clearance/approval and sustain commercial availability.
• Participate on development project teams, providing regulatory requirement information.
• Prepare technical documentation for CE‑marking and maintain registrations outside the EU.
• Review and approve change controls, supplier evaluations, non‑conforming material reports, IFU, labels and promotional material.
• Work with Clinical and Quality to prepare post‑market data for periodic reports and surveillance activities.
• Participate in CAPA investigations, root‑cause analyses, corrective actions and verification of effectiveness.
• Coordinate and document recalls or other field actions and report to regulatory bodies.
• Participate in notified body, FDA and internal audits and respond appropriately.

Required profile

• BA/BS degree or equivalent experience; scientific field degrees preferred.
• 3+ years of regulatory affairs experience in the medical device industry.
• Familiarity with FDA and EU regulations, CE‑marking and Health Canada requirements.
• Experience with FDA interactions, recalls, adverse event reporting and post‑market surveillance.
• Strong analytical abilities, attention to detail and excellent oral and written communication skills.

Required skills

• Proficiency in Microsoft Office (Outlook, PowerPoint, Word, Excel).
• Knowledge of FDA and EU medical device regulatory requirements.
• Experience preparing regulatory submissions, supplements and amendments.
• Ability to review and approve IFU, labels and promotional materials.

What we offer

• Comprehensive medical, dental and vision insurance plus wellness and mental‑health resources.
• Competitive 401(k) plan with immediate company match and financial planning services.
• Generous paid time off, flexible work hours and flexible work‑arrangement options.
• Opportunities for continuous learning, mentorship and tuition reimbursement.
• Recognition programs, bonuses, awards and special events.
• Supportive community culture with volunteer opportunities and sustainability initiatives.
• Competitive compensation range of $107,203 – $160,804 per year, with potential bonuses.