Regulatory Compliance specialist or Manager

hace 2 meses

DonostiaSan Sebastián, España Merlin Digital Partner A tiempo completo

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.

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