Manager, Regulatory & LifeCycle Compliance
Manager, Regulatory & LifeCycle Compliance
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Job Description
Is your focus on regulatory excellence and are you prepared to act as the leader of a team that ensures market readiness and ongoing compliance for innovative medical devices Join GN as our new Manager of Regulatory Lifecycle and Compliance.
The team you will be part of:
You will lead a team of 7 specialists responsible for ensuring lean compliant regulatory processes across both new product introductions and sustaining projects. This role sits within Corporate Quality in the Development Centre Hearing and reports to the Director of Regulatory Operations Akanksha Roy.
Regulatory Operations (RO) at GN plays a pivotal role in shaping and maintaining the regulatory framework that supports our global product portfolio. We work closely with internal and external stakeholders to ensure compliance and efficiency amid evolving regulatory requirements while executing on the regulatory strategy.
Your contribution is appreciated and you will:
Lead and develop a skilled team of regulatory specialists
Operational as a subject matter expert (SME)
Oversee regulatory impact assessments change management audits and CAPA
Monitor regulatory intelligence and work as per SAFe practices
Ensure continuous improvement in regulatory process compliance
To perform well in the role we imagine that you bring:
Experience in people management
Masters degree in engineering chemistry software or similar
Extensive background in medical device regulations (e.g. ISO 13485 MDR 2017/745 FDA 820 510(k) MDSAP)
Experience with global regulatory impact assessments audits and SOP development
Fluent English communication skills
Cultural awareness
A can do attitude
Personal Attributes:
Composed and effective leadership demeanor
Effective stakeholder management and collaboration skills
Clear communicator and active listener
Organized and forward thinking in planning and execution
Why GN
At GN we are highly responsive to regulatory changes which enables us to consistently enhance our processes and align with our business strategy says Cindie Vandfeldt Regulatory Affairs Manager.
We encourage you to apply
Were committed to inclusive hiring. We value mindset and motivation as much as experience. If you bring relevant skills and a true interest in regulatory excellence we encourage you to apply.
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
Submit your application by August 31 2025 via the APPLY link. Applications are reviewed on a rolling basis.
Short on time Just send your CV and a few lines about your motivation.
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:
Manager
Employment Type
Full-Time
