Regulatory and Quality Manager

Il y a 7 mois

Lyon e, France Dr. Schär France Temps plein

In our 18 sites in eleven countries, we work for our mission and a global market. All over the world, people with special nutritional requirements trust in the expertise of Dr. Schär.

The French medical division includes two Business Units (Renal and Gluten-Free). With a growing company and business, for our site located in Lyon with a permanent contract, we are looking for a Regulatory and Quality Manager.

**As Regulatory and Quality Manager for Dr. Schär France, you bear the responsibility of the company’s compliance with local and international health and retail regulations alongside the Managing Director. You develop quality assurance and handle crisis management topics. In collaboration with the Director of Global Quality Assurance & his team in the group Headquarters, you’ll report to the Head of Medical Affairs France and assume the following missions**:
**Regulatory Affairs Leadership**
- Lead regulatory watch and monitor new regulations, keeping abreast of French regulations concerning food, health authorities, and social security requirements.
- Manage all regulatory dossiers required for French market (and deal with different authorities such as DGCCRF, CEPS, HAS ).

**Crisis Management**
- Define in collaboration with QA global local crisis management policy depending on health and retail areas regulations.
- Act as the key French quality coordinator/reference in crisis situations, such as product recalls, withdrawals, and managing any negative publicity.

**Quality Management**
- Design and execute the entity Quality Policy in all fields and in cooperation with all teams.
- Design the quality assurance document system, fulfill quality documents in general.
- Develop and evaluate quality training programs.
- Proactively address and respond to CRM quality claims from customers and consumers, ensuring timely and effective resolution.
- Develop, approve, and ensure compliance with procedures.
- Supervise internal and external audits, document annual reviews and participate in assessments.
- Manage and monitor product quality complaints.

**Translation and Documentation**
- Translate product flow charts and data sheets from English to French, ensuring regulatory compliance in translation.
- Compile and manage QA certificates in a centralized database.

**Customer Communication and Compliance**
- Be the central point for all consumer and customer inquiries, providing accurate information on ingredients, allergens, and nutritional values as well as nutritional and health claims.
- Ensure packaging compliance through meticulous checks, encompassing language, quality, legal, and ingredient aspects.
- Guarantee compliance of all communication supports to different areas regulations.

**Industry Compliance**
- Monitor and adapt to new/local QA certifications, addressing new requirements/demands from customers promptly.
- Stand for the main point of contact for the competent authorities.

**Corporate Liaison**
- Serve as the crucial link between the local team and corporate QA/Regulatory, providing necessary support and input.

**Pharmaceutical-assimilated operations**
- Monitor and oversee the entity’s operations about medical information, nutrivigilance, promotion, distribution and storage, lot tracking and withdrawal
- Sign, after review, the request for marketing authorizations (MA).
- Ensure that transport conditions guarantee the proper conservation, integrity, and security of the products.
- Handle products reimbursement dossier management with health authorities, including monitoring LPPR tips changes on our products.

**Qualifications and Skills**:

- Full-time position.
- Proven experience in French Regulatory affairs and Quality Management.
- Fluent in English with expertise in technical terminologies of the specialized nutrition and health industry.
- Knowledge of products labeling in the EU.
- Adaptable team player with excellent verbal and written communication skills and intrapreneurial mindset.

**Salary**: 55 to 60k package.
With equal skills, all our positions are open to people with disabilities.

**Why join us?**
- A solid group for decades
- A young subsidiary and a stimulating business project
- A friendly and ambitious spirit
- Effective insurance, sports classes at lunchtime, remote work up to 2 days a week
- Let’s discuss it: apply

**Recruitment process**

Type d'emploi : Temps plein, CDI
Statut : Cadre

Rémunération : à partir de 50 000,00€ par an

Avantages:

- Prise en charge du transport quotidien
- RTT
- Travail à domicile occasionnel

Programmation:

- Flextime

Types de primes et de gratifications:

- 13ème Mois

Expérience:

- réglementaire: 4 ans (Requis)

Langue:

- Anglais (Requis)
- Français (Requis)

Lieu du poste : En présentiel

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