Ballerup, DNK
4 days ago
Manager, Regulatory & LifeCycle Compliance
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 + Master’s 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** We’re 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 July 30, 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** GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts. GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history – fostering a sense of community, openness, and understanding. By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them. **The GN-owned brands that are responsible for bringing these technologies to life:** + Medical grade hearing technology: ReSound (https://www.resound.com/en) , Beltone (https://www.beltone.com/en) , Interton (https://www.interton.com/en) , Jabra (https://www.jabra.com/hearing) + Professional collaboration: Jabra (https://www.jabra.com/) , BlueParrott (https://www.emea.blueparrott.com/) , FalCom (https://falcom.gn.com/) + Gaming, calls and media: SteelSeries (https://steelseries.com/) , Jabra (https://www.jabra.com/) Founded in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN’s solutions are sold in around 100 countries across the world. If you would like to learn more about us, visit our homepage gn.com or click on our different brands. You can also connect with us on LinkedIn (https://www.linkedin.com/company/gn-store-nord/) , Facebook (https://www.facebook.com/gnstorenord/) and Twitter (https://twitter.com/gnstorenord) . We are a Equal Opportunity Employer that values a diverse and inclusive workforce. We do not discriminate on the basis of race, color, national origin, religion, age, gender identity, sexual orientation, marital status, disability, genetic information, veteran status, or any other basis prohibited by federal, state, or local law. Women, minorities, veterans, LGBTQIA+ individuals, and persons with disabilities are encouraged to apply. Come join our team!
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