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.
J&J MedTech is looking for a Senior Regulatory Affairs Manager based in Moscow.
Position summary:
Serves as the Regulatory Affairs Lead for Russia and CIS region for Electrophysiology/NV and ensures regulatory compliance and access to market for JnJ medical devices.
Responsibilities:
- Ensures compliance with appropriate laws and regulations in Russia region; establishes processes and procedures for requirements monitoring, impact assessments, compliance strategies. Makes sure that Russia requirements are fed to Business Unit and regional leads.
- Manages the team of RA professionals.
- Oversights on Regulatory Affairs operations within the region; is responsible for delivering on components of the Regulatory Affairs strategic plan; reviews regulatory strategies and identifies gaps that may impact implementation; translates the Regulatory Affairs portfolio strategy into executable plans; ensures proper planning and execution of regulatory submissions , co-operates with global planning team; establishes and manages RA processes to ensure timely approvals.
- Participates at Commercial meetings, as appropriate, to understand strategic priorities for the market; is responsible for the RA strategy aligned with functional and business strategies, serves as spokesperson for a functional area; provides regular functional updates, flags regulatory risks, co-operates with commercial team leader and supporting functions to ensure uninterrupted product supply.
- Provides leadership, personnel development, training, coaching, and mentoring for the team and direct reports (if applicable); manages succession planning for critical positions; manages budgets and resources, including skilled professionals; co-operates with team and Human Resources to create meaningful development plans for the team.
- Monitors, assesses and builds RA strategy for Russia and CIS markets.
Required Experience:
- Minimum of 8 years’ experience in medical devices Regulatory Affairs
- People management experience
- Advanced English level (verbal and written)
- Strong working knowledge of regulatory and compliance activities in the area of Medical Devices.
- Sound decision-making with available information
- Good problem-solving and sense of urgency skills
- Ability to influence at all levels of the organization with good negotiation skills
