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Lead regulatory and compliance design projects for drug delivery devices, managing the process from requirements through to industrialization and post-marketing. Collaborate with development teams and production sites to ensure normative compliance and handle submissions to authorities and notified bodies.
Requires an engineering degree and at least 5 years of professional experience in the medical devices or combination products industry. Must possess deep knowledge of MDR 2017/745, ISO 13485, and eCTD Module 3 CMC, with fluency in English.
With sales of €700m and 3,300 employees worldwide, Nemera is one of the leading global manufacturers of complex drug delivery systems for the pharmaceutical industry, offering to patients a broad product portfolio which includes inhalation devices, injection devices, nasal and dermal pumps and ophthalmic delivery devices. Nemera has built very long lasting, strong relationships with the leading global pharmaceutical companies globally by providing high quality development, industrialization and manufacturing services. Nemera develops and manufactures its own IP product platforms but also offers also fully custom developments and contract manufacturing.
Nemera’s manufacturing sites are located in the US, France, Germany, Brazil and Poland. The headquarters and Innovation Center for early device design and development are located in France (Lyon).
We have big ambitions at Nemera! We are growing our franchises and strengthening our capabilities.
(CDI)
We are looking for a unique person ready to make a difference and join our Compliance & Regulatory team as Regulatory & Compliance Project Manager F/M/X, based in Lyon (7e).
Within Nemera’s headquarters, you will lead the regulatory & compliance design projects of drug delivery devices. You will report to the Global Regulatory & Compliance Leader and you will work closely with the development team, from requirements through to design, development, industrialisation, post marketing, quality, covering all aspects from defining regulatory strategies, and supporting quality management plans through to QMS development and process improvement.
Requirements:
Fluent in English (as it is our company language).
You will be successful here if you are:
· Passionate about growing a business
· Enjoy working as a team
· Proud to make products that improve patients’ lives
· And go the extra mile to deliver on your commitments
At Nemera, our patient-first purpose is at the heart of who we are. We foster a culture of care that gives us the power to do what’s right — for patients, customers and our people. As a team, we’re wired for growth. Passionate. High-energy. High-impact.
We are committed to fostering a work environment that values and celebrates difference, which is fair and equitable, and is enriched by openness, curiosity and accountability. Everyone at Nemera has a role to play and Diversity and Inclusion is everyone’s responsibility. Because when everyone is included, Nemera wins!
That is why, Nemera is an equal opportunity employer and, in accordance with our diversity policy, we review all qualified applications including those of people with disabilities.
We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group, if you want to discover more about Nemera, please look at our website www.nemera.net
Our Recruitment Process
We believe in a transparent and straightforward recruitment process to ensure a great fit for both you and our team.
Here's what you can expect:
- CV Review: Upon receiving your CV, our Talent Acquisition Team will review it to assess your qualifications for the role.
- Initial Screening: If your profile matches our requirements, you'll be invited for an initial screening call with a member of our Talent Acquisition Team.
- Interview with Hiring Manager: After the initial screening, you'll have an interview with the Hiring Manager to discuss your experience, skills, and fit for the role in more detail.
- Interview with N+2: Following the Hiring Manager interview, you'll meet with the next level of management (N+2) for further evaluation.
- HR Manager Interview: The final step involves an interview with our HR Manager to discuss company culture, benefits, and other HR-related topics.
- Offer: If all goes well, you'll receive an offer to join our team!
We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group, if you want to discover more about Nemera, please look at our website www.nemera.net
Know someone at Nemera? We have a Referral Program so, be sure to have them submit you as a referral prior to applying for this position!
Chez Nemera, nous valorisons la diversité et l'inclusion et nous nous engageons à créer un environnement de travail où tous les employés sont traités avec dignité et respect.
Nous sommes fiers d'être un employeur offrant l'égalité des chances et nous encourageons les candidatures de toutes les origines, genres, orientations sexuelles, âges, et capacités.
As a world-leading drug device combination solutions specialist, our purpose of putting patients first enables us to design and manufacture devices that maximize treatment efficacy. We are the utmost holistic partner and help our customers succeed in the sprint to market. From early device strategy to state-of-the-art manufacturing, we're committed to the highest quality standards. Agile and open-minded, we work with our customers as colleagues. Together, we go the extra mile to fulfill our mission. Nemera’s services and products cover five key delivery routes: ● Ophthalmic (preservative-free multidose eyedroppers) ● Nasal, Buccal, Auricular (pumps, valves and actuators for sprays), ● Inhalation (pMDI, DPIs) ● Dermal and Transdermal (airless & atmospheric dispensers) ● Parenteral (auto-injectors, pens, safety devices & implanters) At Nemera, we put patients first when designing, developing and manufacturing drug delivery devices because we know that accurate dosing and ergonomics contribute to patients completing their treatment. Whether they are Nemera proprietary or customer owned, our devices receive the utmost care because we know how critical they are for patients’ health and well-being. Interested in joining a team that truly enjoys working together and prides itself on being at the forefront of innovation and quality? Do you always go the extra mile to deliver on your commitments? Want to feel proud of your work because it improves patients’ lives? If you're ready to help us grow our business and make a real difference, please visit https://www.nemera.net or contact us at [email protected].
Offices: 63, Avenue Tony Garnier, Lyon, Auvergne-Rhône-Alpes 69007, FR · 17, Route d’Eu, Le Tréport, 76470, FR · Rheinwaldstrasse 10, Neuenburg am Rhein, 79395, DE · 600 Deerfield Parkway, Buffalo Grove, Illinois 60089, US
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