Associate Director, Regulatory Affairs, MSM- EP/NV

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. Partner with global and regional Regulatory Affairs teams, commercial teams, distributors, and business partners to provide regulatory guidance and strategic support. Act as Regulatory Affairs Lead or representative on cross-functional projects and regulatory initiatives. Ensure compliance of the medical device portfolio with applicable regulatory requirements and company policies. Provide regulatory support for tenders, reimbursement activities, distributors, commercial operations, and franchise teams. 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. Identify, assess, and escalate regulatory risks while driving effective mitigation plans. 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.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

• 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.