Regulatory Affairs Head

An international company has opened a competition for the position of Regulatory Affairs Head (Medical devices)

Responsibilities:

• Provide coaching to the Regulatory team in various aspects of management (HR matters, budgets, resource allocation);
• Influence through knowledge power to guide business managers at every stage during product planning to product launch;
• Responsible for the budget of the Regulatory function for ensuring that costs are efficiently managed within the budgets;
• Ensure the Regulatory compliance of all labeling and support change control activities for our products;
• Engage in cross functional team activities from initial stages of product planning through till securing government approvals;
• Educate team members appropriately to ensure accurate understanding of regulatory requirements and compliance;
• Ensure the Company complies with current Local Health Authority regulations in Russia and CIS and Division Guidelines for RA;
• Proactively engage with regulators and health officials and maintain a positive relationship;
• Educate management on any likely changes in the regulatory environment that may affect business;
• Be the face of the organization to regulators, participate in appropriate forums and convey the Company’s point of view on all relevant matters;
• Provide strategic planning and leadership to the Regulatory department by ensuring that appropriate structures, systems, competencies and values are developed;
• Plan, organize and implement strategies and perform activities required to procure Regulatory approval for new and modified product lines and ensure the life cycle management of the complete portfolio of legacy devices;
• Ensure that the interfaces between Regulatory and other departments are managed optimally;
• Ensure effective team communication throughout the Regulatory department through the application of suitable reporting systems and structures and the identification and provision of appropriate training;
• Notify senior management of any notifications by Health Authorities or Regulatory Body for inspections, visits, permit renewals or licenses and support Competent Authority audits on the Regulatory Affairs part.

Requirements:

• 5 years+ of deep expertise in medical devices registration, dossier update and registration update processes;
• 2 years+ of people management experience;
• Good knowledge of the current regulation in Russia and CIS and upcoming EAEU regulations;
• Goal oriented, responsible, dedicated and detail oriented;
• Excellent communication skills, good in listening, good problem-solving and influential skills;
• Fluent English & Russian.

Benefits:

• Competitive salary;
• Annual bonus;
• Medical and life insurance;
• VHI;
• Meal allowance;
• Mobile allowance;
• Opportunities for professional development and growth.