Regulatory Affairs Project Manager F/M/X

NEMERA; Lyon; Sur place; EUR 60 000 - 80 000; Plein temps

Résumé du poste

NEMERA in Lyon is seeking a Regulatory Affairs Project Manager (F/M/X) responsible for leading regulatory design projects for drug delivery devices. You will interact with cross-functional teams to ensure compliance with regulatory requirements.

The ideal candidate has an engineering degree, at least 5 years of experience in the medical devices industry, and knowledge of regulatory standards. NEMERA values diversity and inclusion, providing an equitable work environment.

Qualifications

• At least 5 years professional experience.
• Background in the combination products or medical devices industry.
• Knowledge of eCTD Module 3 CMC, CE certification, Notified Body Opinion process.

Responsabilités

• Lead the regulatory design projects of drug delivery devices.
• Prepare and submit regulatory documents to authorities.
• Collaborate with development teams to ensure regulatory compliance.

Connaissances

Regulatory Affairs

Quality Management Systems

Interpersonal Skills

Analytical Skills

Formation

Engineering degree or equivalent

Outils

eCTD

ISO 13485

MDR 2017/745

Description du poste

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 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

• 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
• 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

• 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.