Associate Director, Regulatory Affairs, Electrophysiology

Responsibilities

• Ensure the timely registration and market access of medical devices across the MSM region in compliance with applicable European, FDA, national, and regional regulatory requirements.
• Provide strategic regulatory leadership and partner closely with business stakeholders.
• Lead regulatory affairs activities across the MSM region to support business growth and market access objectives.
• Drive regulatory shaping and outreach initiatives through engagement with Health Authorities, regulatory agencies, and industry trade associations.
• Assess and communicate the impact of changing regulatory requirements on products, registrations, licenses, and business operations.
• Act as Regulatory Affairs Lead on cross‑functional projects and regulatory initiatives.
• Ensure compliance of the medical device portfolio with applicable regulatory requirements and company policies.
• Lead continuous improvement initiatives to strengthen regulatory processes and operational excellence.
• Ensure audit and inspection readiness and represent Regulatory Affairs during internal audits and Health Authority inspections.
• Communicate regulatory compliance updates, risks, and recommendations to leadership and key stakeholders.
• Oversee the Copy Review process and support compliant promotional and non‑promotional communications.
• Lead, coach, and develop direct reports while fostering a high‑performing and collaborative team environment.
• Identify opportunities for process optimization and cost efficiencies.
• Ensure compliance with all applicable quality, legal, ethical, and Healthcare Compliance (HCC) requirements.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Regulatory Affairs, or a related discipline.
• Minimum of 6 years of progressive Regulatory Affairs experience within the Medical Device industry or other highly regulated healthcare environments.
• Demonstrated experience interpreting and applying local, regional, and European medical device regulations.
• Prior people management experience with responsibility for team leadership and development.
• Experience supporting regulatory submissions, registrations, and lifecycle management activities.
• Strong knowledge of EU Medical Device Regulations and regulatory compliance requirements.
• Ability to assess regulatory requirements and translate them into actionable business guidance.
• Established relationships or experience interacting with Competent Authorities and industry associations.
• Excellent communication and stakeholder management skills.
• Strong organizational skills with exceptional attention to detail.
• Strategic mindset with the ability to balance short‑term priorities and long‑term objectives.
• Strong problem‑solving, critical thinking, and decision‑making capabilities.
• Results‑driven with a strong sense of urgency and accountability.
• Fluent English, both written and spoken.