This regional Regulatory Affairs leader defines and drives EMEA and CIS regulatory strategies, ensuring timely, compliant, and cost-effective market approvals aligned with business goals. The role partners closely with commercial, operations, and internal platform teams to harmonize regulatory approaches, support market access, and foster a collaborative, high‑performing regulatory function across EMEA.
- Culture: Build and maintain an engaged culture that is tied to the Merit Way and the RA Manifesto.
- Strategic alignment: Collaborate with key stakeholders to ensure alignment of regulatory goals and objectives with the strategic priorities of the business.
- Stakeholders: Develop and maintain strong strategic partnerships with key stakeholders, especially the EMEA commercial team, EMEA Operations, business (Platform) Leadership and Quality Assurance.
- Regulatory Activities: Oversee all regulatory activities within EEMEA/CIS/EU (non‑CE mark) to ensure compliance with evolving country specific regulatory requirements.
- Recall Reporting: Oversee reporting of field actions within EEMEA/CIS.
- Product/Region Knowledge: Maintain deep regional regulatory knowledge within the team to ensure optimal regulatory strategies are developed and essential data needs are identified early in the process.
- Submissions: Partner with the other internal (Platform) RA team to oversee preparation and execution of regulatory strategies by upholding rigorous standards of accuracy, timeliness, compliance and excellence in regulatory strategy and submissions.
- Communication with Regulators: Oversee and effectively manage communications with regulatory authorities, ensuring all interactions strengthen Merit's reputation and credibility.
- License portfolio: Manage the regulatory license portfolio by maintaining ongoing compliance with local requirements and optimizing the portfolio with commercial strategies.
- Team Leadership: Lead talent initiatives, including interviewing, hiring, onboarding, mentoring/coaching, performance reviews, and corrective action, to build an engaged and high‑performing team.
- Processes: Create, maintain, and continuously improve regulatory processes, procedures and policies.
- Budget & Resources: Develop and manage regulatory budgets and resource allocation to ensure optimal use of resources to achieve departmental and organizational goals and priorities.
- Compliance: Ensure compliance with relevant regulatory requirements, including promotion and advertising.
- Advocacy: Monitor regulatory trends and changes across the region to ensure Merit is proactively involved in shaping new regulations/guidance and guiding all stakeholders in anticipating, understanding and complying with new requirements.
- Data Maintenance: Oversee the timely maintenance of regulatory data, ensuring a high degree of accuracy and compliance within the various platforms and systems.
- Business Development: Support Platform RA in conducting due diligence activities, as needed. Develop and execute RA strategies for integration of new acquisitions/divestments.
- Audits: Represent Regulatory Affairs in audits/inspections leading to successful outcomes and fostering a culture of accountability, compliance and continuous improvement.
- Bachelor's degree (Master's degree preferred) in life sciences, engineering, regulatory affairs or a related discipline.
- 8+ years of progressive Regulatory Affairs leadership experience in the medical device industry.
- Proven track record in leadership roles, including direct management of regulatory teams within a global organization.
- In-depth knowledge of regulations in primary EEMEA/CIS markets.
- Relevant regulatory certifications (e.g., RAC) strongly preferred.
- Good business acumen.
- Communicates with clarity to all the stakeholders.
Salarisomschrijving
€80000 - €120000 monthly