REGULATORY COMPLIANCE SPECIALIST OR MANAGER (MDR & ISO )

We are Merlin Digital Partner ! A leading IT and Digital headhunting company who stands out from the crowd, boasting over a decade of experience.
We've successfully collaborated and played a pivotal role in the growth of industry heavyweights such as Wallapop, Glovo, Banc Sabadell, and Factorial, among others.
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Our mission is to revolutionize companies by seamlessly integrating top-tier talent.
What sets us apart is our in-depth understanding of each partner (being their best influencer!), addressing not only their needs but also capturing their essence.
We are currently looking for a  Specialist Regulatory Compliance (PRRC) Our Partner, is a start-up that is developing and will commercialize medical devices, increasing the effectiveness of assisted reproductive treatments.
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) and the requirements of ISO .
The PRRC is critical in maintaining the company’s commitment to regulatory compliance and product safety.
The Role.
O versee the regulatory compliance of all medical devices, ensuring conformity with MDR and ISO .
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), 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 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 , ISO , and related regulatory frameworks.
Experience in 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.