Regulatory Compliance specialist or Manager (MDR & ISO...

We are Merlin Digital Partner, a leading IT and Digital headhunting company with over a decade of experience. We've successfully collaborated with industry heavyweights such as Wallapop, Glovo, Banc Sabadell, and Factorial.

Our emphasis lies in people-centric approaches and optimizing selection processes. Our mission is to revolutionize companies by seamlessly integrating top-tier talent. We are currently looking for a Specialist Regulatory Compliance (PRRC).

The Mission:

The Person Responsible for Regulatory Compliance (PRRC) ensures that the company's medical device products are in full compliance with the European Union's Medical Device Regulation (MDR) 2017/745 and the requirements of ISO 13485. The PRRC is critical in maintaining the company’s commitment to regulatory compliance and product safety.

The Role:

• Oversee the regulatory compliance of all medical devices, ensuring conformity with MDR and ISO 13485.
• Liaise with Notified Bodies and Competent Authorities for regulatory matters.
• Ensure the technical documentation and EU Declarations of Conformity are up to date and compliant.
• Supervise post-market surveillance and vigilance activities, ensuring timely reporting of incidents.
• Monitor compliance with the requirements concerning the qualification and classification of medical devices.
• Conduct internal audits to verify compliance with regulatory requirements.
• Participate in strategic planning and provide regulatory guidance.
• Ensure all staff are informed of regulatory obligations and changes in regulations.
• Maintain an in-depth understanding of global medical device regulations and standards.
• Ensure that the distribution of medical devices within EU member states complies with the regulatory requirements, including oversight of post-market surveillance, vigilance, and maintaining traceability throughout the supply chain.

Key Activities:

• Keep abreast of regulatory updates and interpret changes to ensure company-wide compliance.
• Collaborate with D&D, Quality Assurance, and other departments to ensure regulatory considerations are integrated into the product lifecycle.
• Manage the preparation and submission of regulatory filings and registrations.
• Facilitate training programs on regulatory requirements for employees.
• Act as the point of contact for regulatory authorities and Notified Bodies.

What we expect from you:

• Bachelor’s or Master’s degree in life sciences, engineering, legal, or another relevant field.
• At least 2 years of experience in regulatory affairs within the medical device industry.
• Detailed knowledge of MDR 2017/745, ISO 13485, and related regulatory frameworks.
• Experience interacting with regulatory authorities and Notified Bodies is preferred.
• Previous experience in a compliance or regulatory leadership position is advantageous.
• Strong analytical and strategic thinking skills.
• Excellent communication skills with the ability to articulate regulatory requirements.
• Thorough and meticulous with documentation.
• Leadership skills with the ability to influence and drive organizational compliance.
• Proactive and capable of working independently.
• Good command of the English language.

Benefits:

• Opportunities for professional growth and career advancement.
• A dynamic, innovative work environment where creativity and new ideas are encouraged.
• Flexible working environment.

Are you ready to be part of the challenge? Contact us!

Please note that this is a Hybrid position (Full time: 40 hours/week)
(On-site 3 days a week in San Sebastian) + Occasional travel may be required for meetings with regulatory bodies or industry events.