Regulatory Compliance specialist or Manager (MDR & ISO 13485), Gipuzkoa

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Regulatory Compliance Specialist or Manager (MDR & ISO 13485), Gipuzkoa

Client:

Merlin Digital Partner

Location:

Gipuzkoa, Spain

Job Category:

Other

EU work permit required:

Yes

Job Views:

4

Posted:

06.03.2025

Expiry Date:

20.04.2025

Job Description:

Merlin Digital Partner: Your Strategic Talent Partner in the Digital Ecosystem

At Merlin, we are a leading talent acquisition consultancy with over 20 years of experience in the digital world. We proudly support startups, scaleups, and corporates in more than 10 countries, helping them find the talent they need to thrive across 15+ areas of specialization.

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 Role:

• Oversee the regulatory compliance of all medical devices, ensuring conformity with MDR and ISO 13485.
• Liaise with the Notified Bodies and Competent Authorities for regulatory matters.
• Ensure the technical documentation and EU Declarations of Conformity are up to date and compliant.
• Supervise the 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 stipulated by the Medical Device Regulation (MDR).

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 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 in interacting with regulatory authorities and Notified Bodies is preferred.
• 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.

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.