Regulatory Affairs Project Manager F/M/X at Nemera Insight Innovation Center

Lyon, Auvergne-Rhône-Alpes, France -

Full Time

Start Date

Immediate

Expiry Date

28 Sep, 26

Salary

0.0

Posted On

30 Jun, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Project Management, Medical Device Design, Compliance, QMS Development, eCTD Module 3 CMC, CE Certification, GMP, ISO 13485, MDR 2017/745, ISO 14971, 21 CFR Part 820, Risk Management, Technical Writing, Audit Support, Stakeholder Management

Industry

Medical Equipment Manufacturing

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 the Regulatory 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

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Responsibilities

Lead regulatory and compliance design projects for drug delivery devices from requirements through to industrialization and post-marketing. Collaborate with development teams and production sites to ensure normative compliance and manage regulatory submissions to authorities and notified bodies.