Associate Director, Regulatory Affairs, Electrophysiology

Johnson Johnson; Diegem; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Jobtailor seeks an experienced Regulatory Affairs Lead to register and gain market access for medical devices across the MSM region, ensuring compliance with European, FDA, national, and regional regulations. You will lead regulatory activities, collaborate with stakeholders, manage submissions, and drive process improvements, audits readiness and relationships with authorities.

Fluent English required; minimum 6 years in medical device regulatory affairs; strong leadership and strategic

Qualifikationen

• Bachelor's degree in Life Sciences, Engineering, Pharmacy, Regulatory Affairs, or related discipline.
• Minimum of 6 years regulatory affairs experience in medical devices or regulated healthcare.
• Experience interpreting local, regional and EU medical device regulations.
• People management experience with team leadership and development.
• Experience supporting regulatory submissions, registrations and lifecycle management.
• Strong knowledge of EU Medical Device Regulations and compliance requirements.
• Ability to translate regulatory requirements into actionable business guidance.
• Established relationships with Competent Authorities and industry associations.
• Excellent communication and stakeholder management skills.
• Strong organizational skills with attention to detail.
• Strategic mindset balancing short- and long-term objectives.
• Strong problem-solving and decision-making capabilities.
• Results-driven with urgency and accountability.
• Fluent English, both written and spoken.

Aufgaben

• Ensure timely registration and market access of medical devices across the MSM region.
• Provide strategic regulatory leadership and partner with business stakeholders.
• Lead regulatory activities to support growth and market access objectives.
• Drive regulatory shaping and outreach with Health Authorities and industry bodies.
• Assess impact of regulatory changes on products, registrations, licenses, and operations.
• Act as Regulatory Affairs Lead on cross-functional projects.
• Ensure portfolio compliance with regulatory requirements and company policies.
• Lead continuous improvement of regulatory processes and operations.
• Ensure audit readiness and represent during inspections.
• Communicate regulatory updates, risks, and recommendations to leadership.
• Oversee copy review and compliant communications.
• Lead, coach, and develop direct reports; foster high performance.
• Identify opportunities for process optimization and cost efficiencies.
• Ensure compliance with quality, legal, ethical, and HCC requirements.

Kenntnisse

Regulatory leadership

Stakeholder management

Team leadership

Strategic thinking

Regulatory submissions

Fluent English

Problem solving

Attention to detail

Ausbildung

Bachelor's degree in Life Sciences, Engineering, Pharmacy, Regulatory Affairs, or related discipline

Jobbeschreibung

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.