RA Specialist

Unity Partners on behalf of our IVD partner

We are currently seeking a Regulatory Affairs Specialist to support our international MedTech partner in maintaining and expanding compliance across the EMEAI region. As RA Specialist, you will play a critical role in enabling regulatory strategy and ensuring compliance of IVD devices and processes with the latest European regulations, including IVDR.

This is a high-impact role where you will act as the Person Responsible for Regulatory Compliance (PRRC), and collaborate with global teams, notified bodies, and local authorities. You'll work cross-functionally across departments to ensure regulatory excellence is embedded throughout the product lifecycle.

Key Responsibilities

As Regulatory Affairs Specialist, you will:

• Act as the PRRC per IVDR (2017/746, Article 15), enabling compliance of IVD products
• Maintain and update technical documentation and EU Declarations of Conformity
• Ensure timely and effective post-market surveillance in line with regulatory obligations
• Support internal stakeholders, distributors, and regional business units with certification and compliance queries
• Lead and maintain product registrations within EUDAMED and across the EMEAI region
• Monitor and report on compliance status, risks, and actions to internal and external parties
• Review marketing, legal, and technical content for regulatory alignment (including SDS, labels, and case files)
• Provide regulatory input during product development and advise on regulatory strategy
• Support compliance with directives including WEEE, REACH, and RoHS
• Liaise with global RA teams and work closely with counterparts in the US and APAC
• Maintain documentation for audit readiness and represent the company during audits

Your Profile

You bring a strong understanding of regulatory frameworks within the IVD or MedTech domain and a proactive mindset. You have:

• A Bachelor's degree in a relevant field (e.g. biology, chemistry, product safety, or life sciences)
• 3+ years of experience in regulatory affairs within the medical device or IVD industry
• Solid knowledge of IVD product registrations and EU regulations (esp. IVDR)
• Experience with ISO 13485; knowledge of WEEE, REACH, and RoHS is a plus
• Strong communication skills in English (written and spoken)
• An international outlook and preferably experience in pathology or lab diagnostics

Organization & Offer

Our partner is known for its dedication to precision diagnostics and laboratory innovation. You'll be part of a collaborative and international environment where regulatory integrity and patient impact go hand in hand. This role offers room to shape regulatory strategy across markets and contribute to life-changing healthcare technologies.

You'll benefit from a competitive compensation package, professional growth opportunities, and direct influence in a quality-driven organization making a real difference.

INTERESTED?

For more information or to apply directly, please contact Christian Steenkamp at (0) or via email at