Associate Director, Regulatory Affairs, MSM- EP/NV

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The successful candidate will provide strategic regulatory leadership, support regulatory policy shaping activities, and partner closely with business stakeholders to ensure ongoing regulatory compliance and successful execution of business objectives. /ppThe Associate Director will play a key role in regulatory strategy development, external regulatory engagement, regulatory compliance oversight, and leadership of a regional Regulatory Affairs team. /ph3Key Responsibilities /h3ulliLead regulatory affairs activities across the MSM region to support business growth and market access objectives. /liliDrive regulatory shaping and outreach initiatives through engagement with Health Authorities, regulatory agencies, and industry trade associations. /liliAssess and communicate the impact of changing regulatory requirements on products, registrations, licenses, and business operations. /liliPartner with global and regional Regulatory Affairs teams, commercial teams, distributors, and business partners to provide regulatory guidance and strategic support. /liliAct as Regulatory Affairs Lead or representative on cross-functional projects and regulatory initiatives. /liliEnsure compliance of the medical device portfolio with applicable regulatory requirements and company policies. /liliProvide regulatory support for tenders, reimbursement activities, distributors, commercial operations, and franchise teams. /liliLead continuous improvement initiatives to strengthen regulatory processes and operational excellence. /liliEnsure audit and inspection readiness and represent Regulatory Affairs during internal audits and Health Authority inspections. /liliCommunicate regulatory compliance updates, risks, and recommendations to leadership and key stakeholders. /liliOversee the Copy Review process and support compliant promotional and non-promotional communications. /liliIdentify, assess, and escalation regulatory risks while driving effective mitigation plans. /liliLead, coach, and develop direct reports while fostering a high-performing and collaborative team environment. /liliIdentify opportunities for process optimization and cost efficiencies. /liliEnsure compliance with all applicable quality, legal, ethical, and Healthcare Compliance (HCC) requirements. /li /ulh3Required Qualifications /h3h3Education /h3ulliBachelor's degree in Life Sciences, Engineering, Pharmacy, Regulatory Affairs, or a related discipline. /li /ulh3Experience /h3ulliMinimum of 6 years of progressive Regulatory Affairs experience within the Medical Device industry or other highly regulated healthcare environments. /liliDemonstrated experience interpreting and applying local, regional, and European medical device regulations. /liliPrior people management experience with responsibility for team leadership and development. /liliExperience supporting regulatory submissions, registrations, and lifecycle management activities. /li /ulh3Knowledge, Skills Competencies /h3ulliStrong knowledge of EU Medical Device Regulations and regulatory compliance requirements. /liliAbility to assess regulatory requirements and translate them into actionable business guidance. /liliEstablished relationships or experience interacting with Competent Authorities and industry associations. /liliExcellent communication and stakeholder management skills. /liliStrong organizational skills with exceptional attention to detail. /liliStrategic mindset with the ability to balance short-term priorities and long-term objectives. /liliStrong problem-solving, critical thinking, and decision-making capabilities. /liliResults-driven with a strong sense of urgency and accountability. /liliFluent English, both written and spoken. /li /ulh3Preferred Qualifications /h3ulliMBA, Master's degree, or other advanced scientific or business degree. /liliExperience within Electrophysiology, Cardiovascular, or broader MedTech businesses. /liliExperience leading regulatory policy shaping, advocacy, or outreach initiatives. /liliExperience supporting multiple countries or regional regulatory activities. /liliProven success leading teams in a matrixed global organization. /li /ulh3Leadership Expectations /h3h3The Successful Candidate Will Demonstrate /h3ulliStrong people leadership and talent development capabilities. /liliAbility to influence across functions and organizational levels. /liliCollaborative and inclusive leadership style. /liliStrong business partnership skills. /liliAbility to navigate complexity and drive execution in a fast-paced environment. /liliCommitment to Johnson Johnson Credo values and ethical leadership. /li /ulh3Why Join Johnson Johnson? /h3pJoin a global organization that is shaping the future of healthcare and delivering innovative solutions that improve lives. ph3Job Function /h3pRegulatory Affairs Group /ph3Job Sub Function /h3pRegulatory Affairs /ph3Job Category /h3pPeople Leader /ph3All Job Posting Locations: /h3pDiegem, Flemish Brabant, Belgium, Zuchwil, Switzerland /ph3Job Description /h3pPosition Overview /ppJohnson Johnson MedTech is recruiting for an Associate Director, Regulatory Affairs, MSM – Electrophysiology (EP). /ppThis role is responsible for ensuring the timely registration and market access of medical devices across the MSM region in compliance with applicable European, FDA, national, and regional regulatory requirements.

This role offers the opportunity to influence regulatory strategy, engage with external stakeholders, and contribute directly to bringing innovative medical technologies to patients across the region. /ppJohnson Johnson is an Equal Opportunity Employer and is committed to creating an inclusive environment for all employees and applicants. /ph3Required Skills /h3h3Preferred Skills: /h3pBusiness Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Managing Managers, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking /p /p