Regulatory Product Compliance Specialist to Corporate Quality
Regulatory Product Compliance Specialist to Corporate Quality
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Job Description
Ensure efficient Market Access
Would you like to play a key role in ensuring smooth and efficient market access for innovative hearing solutions
At GN we empower people to hear more do more and be more. As a Regulatory Product Compliance Specialist youll help us bring people closer through advanced Over-The-Counter (OTC) hearing technologies.
The team you will be part of:
Youll join the OTC part of Regulatory Operations (RO) team within Corporate Quality working alongside skilled this position youll assist with OTC 510 (K) and various other significant initiatives ensuring adherence to global medical device regulations and supporting the development of OTC products.
Your contribution is appreciated and you will:
Identify and analyze risks define mitigations in collaboration with development teams
Plan write and deliver technical documentation- required 510(k) documentation and support 510 (k) submissions to the FDA
Support design control compliance across the organization
Coordinate cross-functional activities to compile and review Design and Technical Files
Facilitate process improvement initiatives for more efficient ways of working
To perform well in the role we imagine that you bring:
A relevant academic degree- electrical or software engineering or similar
Experience in the medical device industry with exposure to design control and regulatory affairs
Familiarity with standards and regulations such as ISO 13485 ISO 14971 MDR IEC 62366-1 IEC 62304 FDA 21 CFR Part 820 and 860 and FDA design control requirements
Experience from development of software driven electronic products
Familiarity with Cybersecurity risks and guidance documents
Experience with regulatory submissions
QMS experience
A keen interest in product development in a regulated environment
Proficient analytical prioritization and stakeholder management skills
A forward-thinking approach and aspiration to enhance effectiveness
Any experience with 510(K) or other regulatory submissions
We encourage you to apply
Dont meet every requirement We still encourage you to applyyour mindset motivation and engagement matter the most. We highly value a mindset and motivation that align with our core values to not only ensure growth for you but for your team and the wider GN organization as well.
We are focused on an inclusive recruitment process
All applicants will receive equal consideration for employment. As such we encourage you to submit your CV without a photo to ensure an equal and fair application process.
Should you have any special requirements for the interview please let the Hiring Manager know upon accepting invitation to interview.
How to Apply
Apply by clicking the APPLY link no later than August 30th 2025. Applications are reviewed on a rolling basis so dont wait to submit yours.
On a time crunch
Feel free to only submit your up-to-date CV including a few sentences outlining your motivation for applying quick and easy.
Join us in bringing people closer
GN brings people closer through our advanced intelligent hearing audio video and gaming solutions. Inspired by people and motivated by innovation we deliver technology that enhance the senses of hearing and sight. We enable people with hearing loss overcome real-life problems improve communication and collaboration for businesses and provide great experiences for audio and gaming enthusiasts.
We hope you will join us on this journey and look forward to receiving your application.
#LI-GNGroup
Required Experience:
Unclear Seniority
Employment Type
Full-Time
