Regulatory Affairs Manager MFX (CDI)

Nemera; Lyon; Sur place; EUR 70 000 - 90 000; Plein temps

Résumé du poste

A leading medical device company in Lyon is seeking a Regulatory Affairs Manager to lead their Regulatory & Compliance team. This role involves managing compliance for drug delivery devices, collaborating with development teams, and supporting customers in regulatory procedures. The ideal candidate has a Master's degree in life sciences, at least 8 years of experience, and strong knowledge of ISO standards. Remote work 2 days a week is possible.

Prestations

Possibility of working from home 2 days per week

Referral Program

Qualifications

• At least 8 years of professional experience in combination products.
• Experience in managing and developing teams.
• Advanced knowledge of ISO 11608 and GMP.

Responsabilités

• Manage the Regulatory & Compliance team of various Business Units.
• Collaborate with development teams to ensure regulatory compliance.
• Support customers in regulatory notification procedures.

Connaissances

Effective interpersonal skills

Ability to multi-task

Analytical skills

Confident communicator

Formation

Masters degree or higher in life sciences

Outils

Adobe Acrobat

Description du poste

We are currently looking for passionate people ready to make a difference in the following open position : Regulatory Affairs Manager F / M / X based in Lyon (7e).

Within Nemeras headquarters you will lead the Regulatory & Compliance design projects of drug delivery devices for one of our strategic products BU.

You will report to the Quality and Regulatory Management of the BU. You will work closely with the development team from requirements through to architecture development industrialisationquality covering all aspects from defining regulatory strategy and supporting quality management plansthrough to QMS development and process improvement.

Job Description

• You will manage the Regulatory & Compliance team of the Business Units Parenteral / Biologics / Intimate Care and Oral.
• 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 Regulatory and Compliance Project Managers in building the product regulatory strategy and regulatory impact assessment of changes linked to the device part and combination products.
• 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 support and guide our customers in their notification procedure particularly in EU US and Canada.
• You will collaborate with different teams to contribute to the continuous improvement processes.
• You will support the Regulatory Team in the preparation verification and approval of regulatory documents and collect normative information needed for the submission to the authorities notified body or customers.
• 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.
• Support development teams during product-specific normative interactions with external stakeholders such as regulatory organisms and customers.
• You may 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
• Collaborate closely with other BUs

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

Then you'll be successful here!

Qualifications : Required profile

• Masters degree or higher in life sciences or sciences (Pharmacist Master in Regulatory Affairs).
• At least 8 years of professional experience (Combination Products)
• Experience in managing and developing teams
• Background in pharmaceutical or biomedical industry in multicultural and interdisciplinary environment.
• Experience in leading Regulatory & Compliance projects in transversal projects
• Experience in quality management system and GMP
• Advanced knowledge and experience in ISO 11608 ISO 23908 ISO 14971 awareness of IEC 60601-1 IEC 62304
• Knowledge of the process of medical device design with products such as syringes pen injectors autoinjectors infusion pumps
• Good English speaking and written
• International committee experience

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
• Confident communicator both verbally and in writing and in presenting information concisely to others in a group or one to one setting
• Analytical and synthetical skills

Some travels are required. We offer the possibility of working from home 2 days per week.

Additional Information :

Why Join Nemera

At Nemera we prioritize patients when creating drug delivery devices understanding that accurate dosing and ergonomics are crucial for treatment adherence. Joining Nemera means becoming part of a team that enjoys working together and consistently delivers on its commitments. We take pride in our work because it improves patients lives.

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

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 linclusion 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 légalité des chances et nous encourageons les candidatures de toutes les origines genres orientations sexuelles âges et capacités.

Remote Work: No

Employment Type: Full-time

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Experience: years

Vacancy: 1