Regulatory Compliance specialist or Manager MDR amp ISO 13485

We are Merlin Digital Partner! A leading IT and Digital headhunting company who stands out from the crowd boasting over a decade of experience. Weve successfully collaborated and played a pivotal role in the growth of industry heavyweights such as Wallapop Glovo Banc Sabadell and Factorial among others.

Our emphasis lies in peoplecentric approaches and optimizing the selection processes. Our mission is to revolutionize companies by seamlessly integrating toptier talent. What sets us apart is our indepth understanding of each partner (being their best influencer!) addressing not only their needs but also capturing their essence.

We are currently looking for aSpecialist Regulatory Compliance (PRRC)

Our Partneris a startup 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 companys medical device products are in full compliance with the European Unions Medical Device Regulation (MDR) 2017/745 and the requirements of ISO 13485. The PRRC is critical in maintaining the companys 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 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 postmarket 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 indepth 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 postmarket surveillance vigilance and maintaining traceability throughout the supply chain.

Key Activities:

• Keep abreast of regulatory updates and interpret changes to ensure companywide 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:

• Bachelors or Masters 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.
• 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)>
(Onsite 3 days a week in San Sebastian) Occasional travel may be required for meetings with regulatory bodies or industry events.