Regulatory Affairs Manager

il y a 1 mois


Issy les Moulineaux, France Abbott Laboratories Temps plein

Abbott is recruiting a Regulatory Affairs Manager to be based in Paris, France.

Your responsibilities include:

  • Review and approval of advertising and promotional materials in France.
  • Preparation and submission to the French Competent Authorities all advertising and promotional materials requiring a prior approval from ANSM per the local regulatory requirements.
  • Notification of placing on the market of new products in France to ANSM.
  • Maintenance of existing notifications, and management of changes to existing notifications, in relation to the new European Medical Device Regulation.
  • Notification to the French competent authorities of new reimbursed products (LPPR declaration)
  • Declaration to the French competent authority of the Economic Operator activity (Affiliate as Distributor)
  • Provide regulatory support to the French Commercial team on tenders and field requests (from sales team, marketing team and reimbursement team): CE certificates, IFU, labels, ISO and EU MDR questions
  • Provide local support and responses to technical queries, e.g. MRI compatibility, latex/PVC content.
  • Support and respond to GDPR questions as appropriate.
  • Support and respond to Privacy Shield questions as appropriate.
  • Provide regulatory affairs support and input to internal and external audits.
  • Provide regulatory training to employees.

Your Profile:

  • Minimum Bachelor degree (degree in a technical or science discipline highly preferred).
  • Knowledge of EU medical device regulations and Quality Management Systems for medical devices.
  • 3-5 years relevant experience within regulatory function in medical devices industry and knowledge of regulatory requirements in France (CE marking)
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Multitasks, prioritizes and meets deadlines in timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Fluency in French and English
  • Strong analytical skills
  • Customer oriented attitude with strong communication skills
  • Attention to detail and accuracy is required.



  • Issy-les-Moulineaux, France Abbott Temps plein

    Abbott is recruiting a Regulatory Affairs Manager to be based in Paris, France. Your responsibilities include: Review and approval of advertising and promotional materials in France. Preparation and submission to the French Competent Authorities all advertising and promotional materials requiring a prior approval from ANSM per the local regulatory...


  • Saint-Amand-les-Eaux, France GSK Temps plein

    **Site Name**: Belgium-Wavre, France - Rueil Malmaison, GSK House, Italy - Siena, Rockville Vaccines, Saint-Amand-les-Eaux **Posted Date**: Mar 27 2023 As Senior Manager, Global Regulatory Affairs, you will have global responsibility (for Regulatory Affairs) of given activities for **RSV OA (regional) within GSK Vaccines.** - Provide input to/manage...


  • Issy-les-Moulineaux, France Kenvue Temps plein

    **Communications & Public Affairs Manager France**-2206064999W **Description** **Johnson & Johnson New Planned Consumer Health Company,** based in Skillman, N.J., is one of the world's largest consumer health and personal care products company. Our consumer companies produce many of the world's most trusted brands, among them JOHNSON'S® Baby, BAND-AID®,...


  • Issy-les-Moulineaux, France Edenred Temps plein

    Take a step forward and let Edenred surprise you. Every day, we deliver innovative solutions to improve the life of millions of people, connecting employees, companies, and merchants all around the world.  We know there are hundred ways for you to grow. With us, you will expand your skills in a multicultural, challenging, and dynamic environment.  ...


  • Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **Purpose of the position** - ** Be responsible for Regulatory Submission and Life Cycle Management for assigned products and to identify and then communicate the implication of upcoming regulations that may impact the process. This also includes Geoexpansion and ESG projects.**: - ** Develop and implement regulatory strategies for the assigned projects and...


  • Issy-les-Moulineaux, France Eutelsat Temps plein

    Join Eutelsat and use your skills to contribute to innovative projects. Eutelsat is one of the world's leading commercial satellite operators with a fleet of about 40 satellites. As a space pioneer with over 40 years of experience, our mission is to provide satellite capacity. Our satellites are used to broadcast television channels and packages, transmit...

  • Global Labelling Manager

    il y a 1 mois


    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **Summary / purpose of the position** **To develop and maintain Core labelling documents and support USPI/other local product information throughout the product life cycle in accordance with Ipsen Processes for assigned product(s)** **To provide labelling guidance to support product teams and senior management in defining labelling strategy** **To provide...


  • Issy-les-Moulineaux, France Transdev Temps plein

    **Transdev is looking for a Junior Project Manager (M/F) (6 months Internship)** **Join an international Group with strong local presence** World leader in the **mobility sector,** Transdev Group develops and operates public transportation solutions at urban, regional and international scale. We are a **multimodal operator**, providing daily service to...


  • Issy-les-Moulineaux, France Johnson & Johnson Temps plein

    Johnson & Johnson is the largest and most broadly-based healthcare company in the world. We’re producing life-changing breakthroughs every day and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track...


  • Issy-les-Moulineaux, France The International Air Transport Association Temps plein

    Employment Type: Permanent Contract Duration:  About the team you are joining Reporting to theArea Manager, France, Belgium, Netherlands & Southern Europe, the incumbentwill liaise with member airlines and other relevant industry and governmentstakeholders across the area to maximize the value of their membership inIATA and implementing IATA...


  • Issy-les-Moulineaux, France Johnson & Johnson Temps plein

    Au sein de la Direction des Affaires Pharmaceutiques, le chargé d’affaires pharmaceutiques s’assure de la conformité des activités opérationnelles des produits dont il a la charge dans le respect de la réglementation en vigueur: - S’assurer que l’ensemble de l’information promotionnelle et scientifique est en conformité avec la...


  • Issy-les-Moulineaux, France Warner Bros. Discovery Temps plein

    **Chaque grande histoire a un nouveau départ, et la vôtre commence ici.** **Bienvenue chez Warner Bros.** **Discovery... l'étoffe dont sont faits les rêves** **Qui sommes-nous...** Lorsque nous disons l'étoffe dont sont faits les rêves, nous ne faisons pas seulement référence au monde des sorciers, des dragons et des super-héros, ni même aux...

  • Aml Compliance Officer

    il y a 2 jours


    Issy-les-Moulineaux, France Sodexo Benefits & Rewards Services Temps plein

    **Benefits & Rewards Services - Compliance Competence Centre** Compliance Officer At Sodexo Benefit and Reward Services (BRS), we’ve made our mark on the world by helping clients give their employees personalized experiences, every day. Our benefit platforms and payment solutions are already used by 440,000 clients and 36 million of their employees in...


  • Issy-les-Moulineaux, France Accor Temps plein

    Company Description Leading the hospitality revolution, Accor is more than a hotel group. With luxury to economy, homestays to resorts, we are a holistic ecosystem of 40 brands in 110 countries, Talent and Solutions, ready to engage with the future’s endless possibilities. Accor has an offer to bring new life to the way you live, work, play and do...


  • Issy-les-Moulineaux, France Johnson & Johnson Temps plein

    JANSSEN recrute un(e) Chargé(e) d’affaires pharmaceutiques, à Issy-les-Moulineaux en CDD Vous souhaitez rejoindre une équipe passionnée travaillant en co-construction avec les autres départements de l’entreprise et impliquée au cœur de l’innovation pharmaceutique ? Vous voulez exercer un métier passionnant qui peut impacter positivement la...


  • Issy-les-Moulineaux, France Coca-Cola Europacific Partners Temps plein

    Vous recherchez de nouveaux challenges professionnels au sein de CCEP ? Nous avons une opportunité pour vous ! **Job Purpose** Support the strategic communications approach to deliver on the company’s long-term growth as well as react to both short-notice developments and crisis situations with tactical, operational communications measures that drive...

  • Quality Manager

    il y a 1 semaine


    Issy-les-Moulineaux, France ORIENT EXPRESS Temps plein

    **Descrizione dell'azienda** ABOUT ACCOR We are worldwide Augmented Hospitality leaders, the best at what we do. Heartists is what we call ourselves, generous, passionate, attentive, and free, whether we are welcoming guests, connecting with our peers, or serving others. Our entire Accor estate expands across the world. With over 300,000 experts committed...


  • Issy-les-Moulineaux, Île-de-France Johnson & Johnson Temps plein

    Chez Johnson & Johnson, nous pensons que la santé est essentielle. Notre force en termes d'innovation dans les soins de santé nous permet de construire un monde dans lequel nous contribuons à prévenir, à soigner et à guérir les maladies complexes, où les traitements sont plus intelligents et moins invasifs, et où les solutions sont personnalisées....

  • Manager Data Governance

    il y a 2 jours


    Issy-les-Moulineaux, France Johnson & Johnson Temps plein

    Johnson & Johnson Enterprise Supply Chain is recruiting for a **Manager Data **Governance **supporting the **Site and Supply Chain Services **team (S&SCS) within **Enterprise Technical Operations & Risk **organization (TO&R), to be located in **France **, **Italy, Belgium, Ireland **or **New Jersey **. The position is for a Product Manager who will support...


  • Issy-les-Moulineaux, France Nestle Operational Services Worldwide SA Temps plein

    Nestlé Waters, part of Nestlé, is the number one bottled water company worldwide_. _We are present in most distribution channels with a _a_ large portfolio of 51 unique brands including Nestlé Pure Life, our No. 1 bottled water brand, _Perrier_ and San Pellegrino. _We’re_ passionate about creating shared _value for society in all kinds of ways: from...