Senior Regulatory Affairs Manager

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