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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