Quality Assurance & Regulatory Affairs Manager

Winid is a talent acquisition consultancy that offers Executive Search, RPO and Talent Solutions.

Our purpose is to drive the growth and fulfillment of individuals and organizations. We facilitate individuals in finding inspiring opportunities and help organizations discover professionals who will take them to the next level. We do this through talent acquisition and development solutions that focus on people, diversity and inclusion, innovation, and cutting-edge technology.

About the client:

Our client is a company that specializes in the development and manufacture of diagnostic and laboratory equipment.

Job description:

We are looking for a Quality Assurance and Regulatory Affairs Manager who will be responsible for ensuring compliance with quality standards and regulatory requirements across operations in Spain and Portugal. This role will require meticulous attention to detail, strong analytical skills, and deep knowledge of regulatory requirements within the medical device industry.

Key Responsibilities:

• Lead efforts to maintain and enhance compliance with all relevant quality standards and regulatory mandates.
• Implement and monitor robust quality assurance systems and processes to safeguard product integrity.
• Stay abreast of changes in regulatory legislation and guidelines in Spain, Portugal, and the broader EU, ensuring timely adaptation of our operations.
• Facilitate internal and external audits, liaising with regulatory bodies as required.
• Work closely with cross-functional teams to integrate quality and regulatory considerations into product development and manufacturing.
  
  

Requirements:

• Experience: At least 3 years in Regulatory Affairs and Quality Assurance within the Medical Devices or IVD industry.
• Education: Bachelor’s Degree in Health Sciences or related field, with ISO certification considered an asset.
• Languages: Proficiency in Spanish and English is mandatory.
• Competences: Exceptional analytical, decision-making, problem-solving skills, and adaptability to learn.
  
  

What We Offer:

• A pivotal position in an esteemed company within the pharma industry
• A competitive salary and benefits package
• An opportunity to make a significant impact on public health outcomes in Spain and Portugal
  
  

If you are driven by quality, dedicated to advancing healthcare through innovation, and ready to make a tangible difference in the medical device sector, we encourage you to apply for this exciting opportunity.

Winid is proud to be an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Discover your next opportunity with us and help shape the future of healthcare.