Regulatory Affairs Specialist

il y a 1 semaine

Paris e, France VIQI Temps plein

**Your responsibilities**
- Maintaining the Technical Documentation for Medical Devices with support of other functions
- Becoming familiar with regulations and standards applicable to specific areas of responsibility, which may include notified body exposure
- Support product registrations including document management
- Support the Medical Device team in approval and document reviews
- Becoming familiar with Quality System requirements for Medical Devices

**Your profile**
- Master degree or equivalent in Regulatory Affairs, Natural Sciences or Engineering and professional experience in the area of Medical Devices Regulatory Affairs or Quality Management for Medical Devices
- EU Medical Device Regulation 2017/745, MDD 93/42 and familiarity with harmonized standards such as EN ISO 13485, EN ISO 14971 or MDCG guidelines
- Ideally experienced with medical devices for the infection prevention business within an internationally operating company
- Demonstrated success in managing processes and projects self-reliantly and managing challenges as the accountable project-owner
- Ability to effectively communicate and collaborate with internal and external stakeholders on an international and virtual base combined with an analytical and solution oriented working manner
- Fluency in French, English and excellent knowledge of MS Office
- Good written and verbal communication skills
- Ability to be flexible and acceptance to travel

Remuneration : 60k - 70k

**based in Lezennes / France or Monheim am Rhein / Germany

  • Specialist, Regulatory Affairs

    il y a 2 semaines

    Paris 1er, France BIORASI LLC Temps plein

    **We are Growing**! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you’ve ever heard of. Biorasi is looking for top...

  • Regulatory Affairs Specialist Emea

    il y a 4 jours

    Paris, France International Flavors & Fragrances Temps plein

    IFF applies expert science to advance market-driven, healthy and sustainable solutions for the food, beverage, dietary supplements, and many other industries. IFF is growing and we are looking for a dedicated and passionate individual to join our Regulatory Affairs team in EMEA! In the Regional Regulatory Affairs Team in EMEA we have an opening for a...

  • Regulatory Affairs Specialist

    il y a 1 semaine

    Paris, France Nanobiotix Temps plein

    Nanobiotix is happy to welcome a CMC manager, regulatory affairs to provide valuable support to our mission to advance groundbreaking nanomedicine solutions. At the forefront of pioneering nanomedicine approaches that could redefine cancer treatment, our team at Nanobiotix is dedicated to creating innovative solutions to impact countless lives across the...

  • Regulatory Affairs Specialist

    il y a 2 semaines

    Paris 8e, France NYCO Temps plein

    Leader européen dans le domaine des lubrifiants pour l’aéronautique et expert dans le développement et la fabrication d’esters synthétiques de hautes performances, nous recherchons **un/une Regulatory Affairs Specialist**, qui travaillera sous la responsabilité du Directeur du service. Le/la Regulatory Affairs Specialist devra assurer les missions...

  • Regulatory Affairs Specialist

    il y a 1 semaine

    Paris 8e, France NYCO Temps plein

    Leader européen dans le domaine des lubrifiants pour l’aéronautique et expert dans le développement et la fabrication d’esters synthétiques de hautes performances, nous recherchons **un/une Regulatory Affairs Specialist**, qui travaillera sous la responsabilité du Directeur du service. Le/la Regulatory Affairs Specialist devra assurer les missions...

  • Specialist Regulatory Affairs

    il y a 2 jours

    Paris, France DSM Temps plein

    **Job title**:Specialist Regulatory Affairs (12 months) **City, country**:Neuilly sur Seine, France **Work mode**:Onsite At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work to not only benefit our People, Customers & Communities but also drive value. Equal access to...

  • Regulatory RIMS Specialist

    il y a 5 jours

    Paris, France Quanta part of QCS Staffing Temps plein

    Regulatory RIMS Specialist - Life Science - 6-Month Contract - France/UK  This is a unique opportunity for a Regulatory RIMS Specialist to join our client – an esteemed partner for regulatory and compliance in healthcare. This is a contract opportunity of at least 6 months within the stunning city of Paris/London. With a globally established presence...

  • Regulatory Affairs Officer 610

    il y a 6 jours

    Paris, France ProductLife Group Temps plein

    In the context of a new project, we are looking for a Regulatory Affairs Officer in medical devises to join our teams in Paris. **Responsibilities**: Write the dossiers and coordinate with the different contributors (R&D, Production, QA, Clinical,..) Ensure that the constitution of the registration dossiers is in accordance with the new European regulation...

  • Regulatory Affairs Officer

    il y a 2 semaines

    Paris, Île-de-France Orion Pharma Temps plein

    DescriptionAbout your roleWe are looking for a motivated and detail-oriented Regulatory Affairs Officer - Veterinary Medicines to join our team for an 18-month temporary position. In this role you will be responsible for supporting the maintenance of marketing authorizations (MA) in various regions. Your focus will initially be on the EU region, with...

  • Regulatory Affairs Compliance Officer

    il y a 1 semaine

    Paris, France JM Huber Corporation Temps plein

    **Summary**: **Key Responsibilities**: - Develop, implement, and manage regulatory strategies to ensure compliance with applicable regulations and standards. - Monitor changes in relevant regulatory environments, interpret new and existing regulations, and communicate potential impacts to key stakeholders. - Provide expert guidance on regulatory matters...