Regulatory Compliance Project Manager FMX

Nemera; Lyon; Sur place; EUR 45 000 - 75 000; Plein temps

Résumé du poste

Join a forward-thinking company as a Regulatory & Compliance Project Manager in Lyon. This role involves leading regulatory design projects for innovative drug delivery devices, ensuring compliance with industry standards, and collaborating with cross-functional teams. You'll be pivotal in preparing regulatory submissions, conducting audits, and participating in standardization committees. If you're passionate about improving patient lives and thrive in a dynamic environment, this opportunity is perfect for you. Embrace a culture that values diversity and inclusion while making a meaningful impact in the healthcare industry.

Qualifications

• 5+ years in regulatory compliance within pharmaceutical or biomedical sectors.
• Experience with CE certification and notified body opinions.
• Knowledge of quality management systems and GMP.

Responsabilités

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

Connaissances

Regulatory Compliance

Project Management

Quality Management Systems

Analytical Skills

Interpersonal Skills

Formation

Engineering Degree

Outils

eCTD

ISO 13485

MDR 2017/745

Description du poste

Regulatory & Compliance Project Manager F / M / X

CDI

We are looking for a dedicated individual to join our Compliance & Regulatory team as a Regulatory & Compliance Project Manager F / M / X based in Lyon 7e.

Within Nemera's headquarters, you will lead regulatory & compliance design projects for drug delivery devices. You will report to the Global Regulatory & Compliance Leader and collaborate closely with the development team from requirements through to design, development, industrialization, and post-marketing quality, covering all aspects from defining regulatory strategies and supporting quality management plans to QMS development and process improvement.

Job Description:

1. Collaborate with development teams and production sites to ensure proper implementation of regulatory and normative activities.
2. Assess resources needed for regulatory and normative activities related to your product platform.
3. Contribute to continuous improvement processes by working with various teams.
4. Prepare, verify, approve, and submit regulatory documents; collect normative information for submissions to authorities, notified bodies, or customers.
5. Draft, verify, and approve plans and verification reports from internal or external laboratories concerning your products.
6. Assist with internal or external audits and propose corrective and preventive actions.
7. Collect and interpret standards, inform product or process managers of changes, analyze gaps, and collaborate across departments to ensure normative compliance.
8. Summarize regulatory and normative requirements.
9. Support Insight teams during product-specific normative interactions with external stakeholders.
10. Participate in standardization committees and external expert groups to understand, anticipate, and influence standards.
11. Conduct detailed analyses of proposed product changes, assess impacts, evaluate normative compliance, and propose corrective measures if necessary.

Qualifications & Requirements:

• Engineering degree or equivalent.
• Minimum 5 years of professional experience.
• Experience in the pharmaceutical or biomedical industry within a multicultural and interdisciplinary environment.
• Knowledge and experience with eCTD (Module 3 CMC), CE certification, Notified Body opinions.
• Experience leading regulatory & compliance projects, especially transversal projects.
• Knowledge of quality management systems and GMP.
• Familiarity with 21 CFR part 820, ISO 13485, MDR 2017/745, ISO 14971.
• Knowledge of ISO 11608 and ISO 23908 is optional.
• Understanding of medical device design processes.
• Proficient in English (spoken and written).
• Strong interpersonal skills, ability to work independently or in a team.
• Effective organizational and time management skills to handle multiple priorities.
• Flexible, adaptable, proactive, and motivated with problem-solving skills.
• Analytical and synthetic thinking abilities.

Competences:

• Knowledge of MDR 2017/745.
• General understanding of regulatory frameworks.

Languages: Fluent in English (company language).

Ideal Candidate Qualities:

Passionate about growing a business, enjoys teamwork, proud to improve patients' lives, and willing to go the extra mile to meet commitments.

At Nemera, our patient-first purpose is central. We foster a caring culture that empowers us to do what's right for patients, customers, and our people. We are growth-oriented, passionate, energetic, and impactful.

We value diversity and inclusion, striving for a fair, open, and accountable environment. Everyone at Nemera plays a role, and diversity is everyone's responsibility. When everyone is included, Nemera wins!

Nemera is an equal opportunity employer, welcoming all qualified applicants, including those with disabilities.

We look forward to your application (preferably in English). Discover more about Nemera on our website.