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Full-time
bachelor degree
Posted 55d ago
~40 hrs/week
Responsibilities
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.
Requirements
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.
Full job description
Company Description
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.
Job Description
Regulatory Affairs Project Manager F/M/X
(CDI)
We are looking for a unique person ready to make a difference and join our Regulatory Affaires team as Regulatory Affairs 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 theRegulatory Afairs Manager (Parenteral and ICO products) 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.
Job Description :
You will collaborate with development teams and with the production site(s) to ensure correct implementation of regulatory and normative activities of the products and concerned production sites.
You will be in charge of the resources assessment needed for regulatory and normative activities under your ownership and product platform.
you will collaborate with different teams to contribute to the continuous improvement processes.
you will prepare, verify, approve, submit regulatory documents and collect normative information needed for the submission to the authorities, notified body or customers.
Participate in the drafting, verifying and approving plans and verification reports from internal or external laboratories concerning products under your ownership.
Contribute and assist when necessary to internal or external audits and propose corrective and preventive actions.
You will collect and interpret elements of the monitored standards, inform product or process managers for the changes, analyze and synthesize gaps and collaborate with other departments of the company to guarantee normative compliance.
You will summarize regulatory and/or normative requirements.
Support Insight teams during product-specific normative interactions with external stakeholders, such as regulatory organisms and customers.
You will participate in standardization committees and external expert groups in order to understand, anticipate and influence existing or new standards.
You will conduct in-depth analyzes of proposed product changes, assessing their impact, evaluating the normative compliance and proposing corrective measures if necessary
Qualifications
Requirements:
Engineering degree or equivalent
At least 5 years professional experience
Background in the combination products or medical devices industry in multicultural and interdisciplinary environment.
Knowledge and experience in eCTD (Electronic Common Technical Document) Module 3 CMC, CE certification, Notified Body Opinion process
Experience in leading Regulatory & Compliance projects in transversal projects
Experience in quality management system and GMP
Knowledge of 21 CFR part 820, ISO 13485, MDR2017/745, ISO 14971.
Knowledge of ISO 11608 and ISO 23908 are optional
Knowledge of the process of medical device design
Good English speaking and written
Travel occasional
Soft skills
Effective interpersonal skills with ability to work in a team or independently.
Ability to multi-task and manage priorities with effective organizational and time management skills
Demonstrated flexibility and adaptability
Highly motivated with a proactive approach to learning and problem solving
Analytical and synthetical skills
Competences
Medical devices
MDR 2017/745
Generic drugs
Languages:
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
Additional Information
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.
Employment Classification: Cadre
Nemera Department: Global Quality & Regulatory
Legal entity: Nemera La Verpillière
Related keywords
Drug Delivery SystemsMedical DevicesCombination ProductsRegulatory AffairsComplianceMDR 2017/745ISO 13485ISO 14971ISO 11608ISO 2390821 CFR Part 820GMPeCTDCMCCE CertificationNotified Body
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
Drug delivery devicesOphthalmicPreservative-freeMultidose eye droppersInhalationNasalEar Nose ThroatNasal spray pumpsPMDIDPI
How many Healthcare jobs are open in Lyon, France right now?
There are currently 245 open healthcare positions in Lyon, France listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Lyon, France?
Companies currently hiring include Babilou, Eurofins Viracor, Dentego, NEMERA, Sanofi, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Lyon, France?
Yes — 58 of the 245 open healthcare positions offer remote or hybrid work (7 remote, 51 hybrid).
How do I apply for Healthcare jobs in Lyon, France?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.