Manager Regulatory Affairs

DNV MEDCERT is an accredited Certification Body for ISO 13485, recognised auditing organization under MDSAP and approved Notified Body for Medical Devices Regulation. We provide global market access by certifying the safety and quality of products and systems to international safety and quality standards and regulations.

Our high professional standards and our sustainable approach guarantee you a forward-thinking work environment, within an organisation that invests in its employees, and is committed to providing you with continued development.

We are looking for a Regulatory Affairs Manager to join our DNV MEDCERT Regulatory Affairs & Quality Management Team in Hamburg. The main focus of the role is to manage DNV MEDCERT’s relationships with designating/ recognizing/ accreditation bodies as related to DNV MEDCERT’s certification (ISO 13485) and conformity assessment programs (MDR 2017/745).

Key responsibilities include:

• Compliance monitoring:
  • Oversight, including collection, internal dissemination and management, of information on the relevant designation, recognition and accreditation requirements for certification and conformity assessment programs
• Oversight of MEDCERT’s ongoing designation, recognition and accreditation procedures at their different phases: application, assessment activities, reporting and decision
• Liaising with designating/ recognizing accreditation bodies, supporting their oversight activities
• Participation in committees and meetings, as required, as regards the continuous development of the auditing and conformity assessment programs

Position Qualifications

• Education (Master’s degree) and equivalent work experience in engineering or natural science
• Good communication skills, verbally and in writing in German and English
• Work experience in the field of regulated products and/or services, preferably in the management/ accreditation/ recognition/ designation of medical devices or pharmaceuticals

We offer:

• Great colleagues who value teamwork and support
• International working environment
• Flexible working hours and focus on work/life balance
• Attractive salary incl. profit share and an employer-supported pension
• Further attractive benefits

Company & Business Area Description

DNV is the independent expert in assurance and risk management, operating in more than 100 countries. Through our broad experience and deep expertise we advance safety and sustainable performance, set industry benchmarks, and inspire and invent solutions.

We are one of the world’s leading certification, assurance and risk management providers. Whether certifying a company’s management system or products, providing training, or assessing supply chains, and digital assets, we enable customers and stakeholders to make critical decisions with confidence. We are committed to support our customers to transition and realize their long-term strategic goals sustainably, and collectively contributing to the UN Sustainable Development Goals.

Equal Opportunity Statement

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity!

About the company

DNV GL is an international accredited registrar and classification society headquartered in Høvik, Norway.

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