Regulatory and Quality Assurance Manager
il y a 3 jours
Dr. Schär is seeking a highly skilled Regulatory and Quality Assurance Manager to join our team in Lyon, France. As a key member of our organization, you will be responsible for ensuring compliance with local and international health and retail regulations.
Key Responsibilities:- Lead regulatory watch and monitor new regulations, staying up-to-date on French regulations concerning food, health authorities, and social security requirements.
- Manage all regulatory dossiers required for the French market, dealing with authorities such as DGCCRF, CEPS, and HAS.
- Define and implement a local crisis management policy in collaboration with the QA global team, 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 negative publicity.
- Design and execute the entity's Quality Policy in all fields, in cooperation with all teams.
- Design the quality assurance document system, fulfill quality documents in general, and 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, translate product flow charts and data sheets from English to French, ensuring regulatory compliance in translation, and compile and manage QA certificates in a centralized database.
- 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, and guarantee compliance of all communication supports to different areas regulations.
- Monitor and adapt to new/local QA certifications, addressing new requirements/demands from customers promptly, and serve as the main point of contact for competent authorities.
- Act as the crucial link between the local team and corporate QA/Regulatory, providing necessary support and input.
- Monitor and oversee the entity's operations regarding medical information, nutrivigilance, promotion, distribution, and storage, lot tracking and withdrawal, sign requests for marketing authorizations (MA) after review, and ensure that transport conditions guarantee the proper conservation, integrity, and security of products.
- 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 an intrapreneurial mindset.
- A solid group with decades of experience.
- A young subsidiary with a stimulating business project.
- A friendly and ambitious spirit.
- Effective insurance, sports classes at lunchtime, remote work up to 2 days a week.
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