Senior Specialist ISO Certification
Offer
- a challenging job within a large pharmaceutical company
- a temporary assignment till 01-09-2025
- contract of Derks & Derks Secondment & Interim
Position
As a Senior Specialist ISO Certification and Regulatory Compliance, you will play a key role in ensuring that the company’s quality management systems meet international standards and regulations. Your primary responsibility will be to lead the ISO certification process for medical devices and combination products, ensuring compliance with European and US FDA regulations. You will also conduct QMS gap assessments and coordinate audits from regulatory authorities, such as Notified Bodies and the FDA. Collaborating with cross-functional teams, you will implement corrective actions and guide continuous improvement efforts. In short, this is an opportunity to be at the heart of ensuring product quality and regulatory compliance for a global healthcare leader. This is a temporary assignment filled through interim or secondment.
Profile
- minimum 5 years of experience in quality management within the medical device or combination products industry
- demonstrated expertise in ISO 13485 and regulatory compliance (21 CFR Part 4, QMSR, EU MDR)
- proven ability to lead QMS gap assessments and manage audits from regulatory bodies
- experience with ISO certification and maintaining quality systems in a regulated environment
- strong communication skills to effectively communicate with cross-functional teams and regulatory authorities
- attention to detail and a proactive approach to problem-solving
- adaptability to work in a fast-paced, dynamic environment
- strong leadership skills to drive change and influence stakeholders, and lead a team
Organisation
Our client is a world leader in the healthcare industry. Through their medicines, vaccines, biological therapies, and support services, they offer health solutions for people and animals in more than 140 countries. They also demonstrate their commitment to an increasing access to healthcare through far-reaching programs that donate and deliver their products to the people who need them. The organisation has three main locations with approximately 4,500 employees. This position is located in Haarlem.
Response
Interested? Please send your resume and motivational letter by e-mail, with reference to MSP/24-320-DD to Marlies Dingemans: info@derksenderks.nl. For more information, please call or Whatsapp Marlies via +31 (0)6 45316342.
Our client has chosen Derks & Derks Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.
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