Regulatory Compliance Expert

hace 6 días


Gasteiz Vitoria, Álava, España Merlin Digital Partner A tiempo completo
Job Description

We are Merlin Digital Partner, a leading IT and Digital headhunting company with over a decade of experience. Our emphasis lies in people-centric approaches and optimizing selection processes. Our mission is to revolutionize companies by seamlessly integrating top-tier talent.

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 Responsibilities:
  • 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.
Requirements:

We are looking for a highly skilled and experienced professional with:

  • 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.
Salary Range:

Our estimated salary range for this role is $80,000 - $120,000 per year, depending on qualifications and experience.



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