Senior Regulatory Affairs Specialist

Regulatory Affairs Manager Job Summary:

This role is responsible for leading the regulatory affairs function in the EMEA region, ensuring alignment with global objectives and business priorities. The successful candidate will provide strategic leadership, oversee international regulatory affairs teams, and ensure adherence to applicable EU and international regulatory obligations.

Main Responsibilities:

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• Provide strategic leadership and oversight for international regulatory affairs teams across the EMEA region.">
• Serve as the designated delegate for Person Responsible for Regulatory Compliance (PRRC) to ensure adherence to relevant EU and international regulatory obligations.">
• Ensure compliance with relevant global regulatory requirements, standards, and internal quality systems for all products, processes, and documentation.">
• Develop, implement, and continuously refine regulatory strategies for new and existing products to support timely market access and business growth.">
• Lead talent development initiatives within the regulatory affairs team, including recruitment, performance management, coaching, and succession planning.">
• Foster strong collaboration with business unit and regional stakeholders to ensure efficient execution of global regulatory strategies and product launches.">
• Provide regulatory oversight for product and process changes, including review of Change Orders and assessment of their impact on regulatory approvals and licenses.">
• Approve and/or oversee the preparation of regulatory submissions for new product introductions, renewals, and variations in the EMEA region.">
• Monitor evolving regulatory requirements and proactively assess their impact on the business, ensuring timely communication and implementation of necessary changes.">
• Collaborate with global regulatory counterparts and technical experts to address complex regulatory challenges and respond to inquiries from health authorities.">
• Act as a regulatory point of contact for internal departments and external stakeholders, providing guidance and resolution of regulatory issues.">
• Lead and support regulatory inspections and audits at the site, ensuring readiness and effective response to findings.">
• Manage regulatory projects, including planning, resource allocation, risk mitigation, and budget oversight, to ensure timely and successful outcomes.">

Requirements:

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• Minimum 5 – 7 years experience in a similar role and medical device background">
• Degree in Regulatory, Biomedical Engineering or Science related discipline">
• Strong understanding of relevant regulations and guidelines">
• Excellent verbal and written communication skills">
• Ability to manage multiple projects and deadlines effectively">
• Ability to analyze regulations and assess their impact">
• Meticulous in preparing and reviewing documentation">
• Ability to identify and resolve compliance issues">
• Ability to guide and motivate a team">
• A relevant degree in life sciences, engineering or scientific qualification; Masters an advantage">
• Experience in regulatory affairs within the medical device industry">

Specialized Skills / Other Requirements:

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• Strong collaboration and influencing skills – both internally and externally">
• Excellent communication skills – both verbal and written">
• Goal oriented for customer and business objectives">
• Coaching/Mentoring skills">

Benefits:

The ideal candidate will have excellent communication skills, a strong understanding of relevant regulations and guidelines, and the ability to manage multiple projects and deadlines effectively. This role offers opportunities for professional growth and development, as well as the chance to work with a dynamic team in the medical device industry.

Travel Requirement:

Approximately 20%

About Us:

We are committed to diversity and inclusion, and we welcome applications from talented individuals who share our values.

Contact Us:

Please note that key responsibilities may evolve and change over time. Diversity fosters innovative thinking and entrepreneurship, and we value our people and diversity.