Compliance Specialist – Design Control

Job title:

Compliance Specialist – Design Control

Company:

Novo Nordisk

Job description

Does MDR, ISO-11608, FDA 21 CFR 820.30 more than ring a bell? Are you passionate about understanding and implementing external requirements for medical devices, and working with many stakeholders across the organisation?If so, apply today and come join us as Compliance Specialist in Device Development at Novo Nordisk based in Hillerød!The position
We are on the lookout for a Compliance Specialist to analyse and guide the implementation of health authorities’ regulations on our marketed product portfolio. You will support and set direction for the department and will be collaborating across the organisation.Key Responsibilities will include:

• Represent the department in various fora identifying, prioritizing, planning and implementing new regulatory requirements for Medical Devices and Combination Products from a global perspective.
• Lead and collaborate effectively in implementation and improvement initiatives of requirements across products, coordinating with the responsible product teams and key stakeholders across the organisation.
• Build strong partnerships with various departments and stakeholders to ensure alignment on product strategies and objectives.

Qualifications
Your experiences include:

• A Degree in Natural Sciences or Engineering (e.g., Engineering, Pharma, Chemistry) or the like – with strong business insight.
• 5+ years of proven experience in the analysis of regulatory requirements within Design Control including implementation planning.
• Strong collaboration skills and experience managing Design Control processes in regulated industries.
• Change management experience is advantageous.
• Fluent in spoken and written English.

As a person, you have excellent collaboration skills, bridge-building abilities, and use a strategic approach to engage stakeholders effectively. You thrive in a dynamic environment with changing priorities, where you leverage your team’s skills, ensuring transparent and effective dialogue on all levels of the organisation.About the department
The position is in Device Development which is part of Novo Nordisk Finished Product Manufacturing Science & Technology (FPMSAT). Device Development holds the design responsibility for Novo Nordisk’s medical devices and delivery systems and is the link between Device R&D and production. In Device Development, the main task is to maintain marketed products as well as develop new variants of existing product platforms. Our deliverables have direct impact on our ability to deliver to the market, on patient safety, and on compliance with the requirements of the authorities. You will join the Technology & Processes team in Device Development. You will be working alongside colleagues with various educations and work experience. You can look forward to an exciting job engaging with multiple stakeholders at global and local level.

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care.Contact
For further information or any questions, please reach out to Jasmin Mahdavi (Manager, Technology and Processes) at: JYMM@novonordisk.comDeadline
9 February 2025
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

Expected salary

Location

Hillerød, Hovedstaden

Job date

Wed, 22 Jan 2025 23:48:50 GMT

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