Specialist, Regulatory Affairs

We are looking at a Regulatory Affairs Specialist to join and complete our team. You will be responsible for the coordination and preparation of document packages to secure timely approvals and maintain market clearance with a primary focus on EU + Turkey and/or other regions as assigned. **Key Areas of Responsibility** (non-exhaustive list**)**: - Leads...

Job Title: Regulatory Affairs SpecialistWe have an exciting opportunity for a highly skilled Regulatory Affairs Specialist to join our growing Clinical Development team in Lyon, France.About the Role:In this newly created position, you will work under the supervision of the Clinical Development Manager and collaborate closely with a full-service CRO. Your...

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...

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...

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...

About the Role:As a Senior Regulatory Affairs Specialist, you will be responsible for leading FDA cycles on complex medtech products. Our ideal candidate has experience in regulatory affairs and is familiar with the FDA's guidelines.Key Responsibilities:Develop and implement regulatory strategies for new product launchesEnsure compliance with relevant...

Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in France. As a key member of our regulatory affairs department, you will be responsible for the preparation, review, and coordination of country submissions in line with our global submission strategy.About Thermo Fisher ScientificAt Thermo Fisher Scientific, we...

Ecolab, Purolite Resins, the world leader in resin-based separation, purification and extraction technology, is seeking a **Senior **Regulatory Affairs Specialist**.** We manufacture products which help our customers around the globe, mainly in pharmaceutical and life science sectors, with technology which are critical to safe manufacture of their products....

Prise de poste non définie BAC +5 Paris Nombre de postes non défini CDI Rémunération non définie **Description du poste et des missions**: **WHO WE ARE** Cellectis is a **global clinical-stage biopharmaceutical** company. **Pioneers and innovators** in our field, our mission is to develop **innovative treatments** for **patients with unmet medical...

**Dental Monitoring** is a MedTech Scale-up experiencing tremendous growth. We are looking for new talents to integrate our team! Dental Monitoring in a few words? - A solution at the cutting edge of artificial intelligence and image analysis in the dental field, enabling remote support for patients and practitioners. - A Tech company in full growth, always...

**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...

**Job Title**: Senior Regulatory Affairs Specialist Job Posting Description **In this role, you have the opportunity to** Ensure that products comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions, and enablers for SaMD products supporting the Cardiologs business within Ambulatory...

**Job Title**: Regulatory Affairs Specialist Philips est un leader mondial dans le domaine des technologies médicales, qui s'engage à améliorer des milliards de vies dans le monde entier et s'efforce à rendre ce monde plus sain et plus durable grâce à l'innovation. Nous sommes animés par la vision d'un avenir meilleur. Le monde et les besoins de nos...

**Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...

Prise de poste non définie BAC +3/+4 Paris Nombre de postes non défini CDI À négocier **Description du poste et des missions**: **ICON plc recrute un Local Regulatory Affairs Associate (LRAL) à Paris et sa région** **_ ROLE:_** L'équipe Global Regulatory Clinical Services (GRCS) d'ICON Biotech Solutions aide les clients d'ICON à naviguer dans les...

The Compliance function is a Second line of defence (2nd LoD) function, responsible for reviewing and challenging the activities of the Group’s businesses (also referred to as “the 1st LOD”) to ensure that they effectively manage as “Risk Owners” the risks inherent in or arising from the conduct of their activities and for which they are...

**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...

**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...

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. **Join Our Team as a** **Regulatory Affairs Project...

**Job Summary** Joining the regulatory team, reporting to Head of Quality and Regulatory Affairs, your mission is to maintain the Quality Management System, with the objective of improving and automating processes - Your simply are the Quality Lead of Implicity - You then manage the roadmap and implement your plan regarding our ISO 13485 certification - You...