Associate Director, Regulatory Affairs

Il y a 2 mois

Paris, France Cpl Temps plein

Job Title: Associate Director,  Regulatory Affairs -  Medical Devices

Job Type: Full Time, Permanent Position

Location: Greater London, UK and some EU locations

Remuneration: Attractive salary and package


An exciting opportunity to join a growing pharmaceutical company that specialises in Cancer and Supportive Care, Gastroenterology and Hepatology. Due to increasing growth the business is looking for an Associate Director, Regulatory Affairs Medical Devices Lifecycle Management to join the team.


As an Associate Director, Regulatory Affairs -  Medical Devices Lifecycle Management you will be responsible for the strategic lifecycle management of the businesses Medical Devices post CE approval and the operational execution management with the Regulatory Service Provider. This includes the responsibility and oversight of all activities required for the successful and smooth integration of new products following launch and all associated on-going regulatory maintenance activities.


Main Responsibilities:

·       To be the primary regulatory point of contact for all medical device queries for the businesses portfolio by providing guidance on regulatory medical device requirements and compliance to brand teams and other areas of the business.

·       Inputting into discussions on projects and questions associated with medical devices anticipating and resolving complex regulatory issues associated with medical devices.

·       Lead an support all post market surveillance activities for the medical device portfolio in the UK, Europe and growth regions.

·       Drive all Regulatory Affairs Medical Device strategies for a global regions.

·       Responsible for NPD activities for devices.

·       To oversee, manage and where required advise the Regulatory Service Provider on medical device maintenance and submission strategies, plans and the preparation of updates to the technical file and regulatory submissions for all medical device related changes.

·       The preparation of high quality documentation for labelling regulatory submissions, following current best practice.

·       To represent Regulatory Affairs Lifecycle Management â Medical Devices internally and externally

·       To maintain up to date knowledge of relevant regulations, guidelines and industry standards and apply in practice through procedures, knowledge sharing and advice to project teams.

·       To manage regulatory intelligence information for medical devices including databases (e.g. NOTIS).

·       To co-ordinate QMS related regulatory activities e.g. deviations and CAPAs as applicable.

·       To manage own workload, including responsible delegation, to ensure agreed regulatory activities are planned, agreed and progressed.


Requirements:

·       BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.

·       Previous experience in Regulatory Affairs is a MUST

·       At least 8 years + experience within the medical device sector and have a sound understand of new registrations and post market surveillance activities.

·       Confident with maintaining medical devices in global regions.

·       Broad regulatory medical device experience, part of which should have been gained operating at a senior level, and good knowledge of worldwide regulatory requirements (including GMP, GLP and BCP).

·       Must have expertise in the development, certification and maintenance of medical device products.

·       Line management or staff oversight/ coaching experience.

·       Experience managing Service Providers is essential.


This role allows the right person to step into a senior role within the business and take responsibility for a growing portfolio of medical devices. Due to the businesses continuous growth this person will have an excellent opportunity to growth and develop. The position also comes with an attractive salary and package.


For more information regarding this role please reach out to lucy.kirkaldy@cpl.com


Please note you must have the full right to work and this employer doesnât offer sponsorship. 

  • Regulatory Affairs Associate

    il y a 1 mois

    Paris, Ile-de-France Meet Temps plein

    Global Regulatory Affairs AssociateWe're currently seeking a Global Reg Affairs Associate for an award-winning pharma company specialising in OTC products! Preparing submissions of license variations, assisting in preparation of regulatory documents, acting as a submission specialist will all be core components of this role!The Regulatory Affairs...

  • Regulatory Affairs Associate

    il y a 3 semaines

    Paris, France Meet Temps plein

    Global Regulatory Affairs Associate We're currently seeking a Global Reg Affairs Associate for an award-winning pharma company specialising in OTC products! Preparing submissions of license variations, assisting in preparation of regulatory documents, acting as a submission specialist will all be core components of this role! The Regulatory Affairs...

  • Regulatory Affairs Associate

    il y a 1 mois

    Paris, France Meet Temps plein

    Global Regulatory Affairs AssociateWe're currently seeking a Global Reg Affairs Associate for an award-winning pharma company specialising in OTC products! Preparing submissions of license variations, assisting in preparation of regulatory documents, acting as a submission specialist will all be core components of this role!The Regulatory Affairs...

  • Regulatory Affairs Associate

    il y a 3 semaines

    Paris, France Meet Temps plein

    Global Regulatory Affairs AssociateWe're currently seeking a Global Reg Affairs Associate for an award-winning pharma company specialising in OTC products! Preparing submissions of license variations, assisting in preparation of regulatory documents, acting as a submission specialist will all be core components of this role!The Regulatory Affairs Associate...

  • Regulatory Affairs Associate

    il y a 2 semaines

    Paris, France Meet Temps plein

    Global Regulatory Affairs Associate We're currently seeking a Global Reg Affairs Associate for an award-winning pharma company specialising in OTC products! Preparing submissions of license variations, assisting in preparation of regulatory documents, acting as a submission specialist will all be core components of this role! The Regulatory Affairs...

  • Senior Manager/ Associate Director, Regulatory

    Il y a 3 mois

    Paris, France Stirling Q&R Ltd Temps plein

    On-site presence in the South of France once per month for 2-3 days. Stirling Q&R, a leading recruitment company, is currently assisting our esteemed client in the search for a highly experienced Senior Manager/Associate Director, Regulatory Affairs. Our client, a renowned global biotech company specializing in oncology, is dedicated to improving treatment...

  • Quality Assurance/ Regulatory Affairs Associate

    Il y a 3 mois

    Paris, France Allurion Temps plein

    We are thrilled to be one of Deloitte's 500 fastest growing technology companies in the US - and now, we are ready to take our success to the next level by going public! This is an incredible opportunity to join our team as a Quality Assurance/ Regulatory Affairs AssociateSpecialist and help us reach new heights. At Allurion, our core values of Audacity,...

  • Regulatory Affairs Director

    il y a 1 mois

    Paris, Île-de-France Proclinical Temps plein

    Proclinical is currently seeking a Regulatory Affairs Director for a part-time position within the Biologics/ATMP/Gene Therapy industry. This role involves organizing and leading scientific advice meetings, collaborating with the FDA, and focusing on Pre IND activities. Position Summary:Organize and lead scientific advice meetingsCollaborate with the...

  • Regulatory Affairs Director Healthcare

    il y a 18 heures

    Paris, Île-de-France Meet Temps plein

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Meet. As a key member of our organization, you will be responsible for ensuring the regulatory compliance of our medicinal products globally.Key ResponsibilitiesRegulatory Lifecycle Management: Manage the regulatory lifecycle of OTC and Consumer products, from initial...

  • EAME Regulatory Affairs Manager

    il y a 3 semaines

    Paris, Île-de-France International Flavors & Fragrances Temps plein

    EAME Regulatory Affairs ManagerCompany: International Flavors & FragrancesWe are seeking a committed Regulatory Affairs Manager to become a key member of our Scent Regulatory Affairs division at International Flavors & Fragrances. In this position, you will be tasked with ensuring adherence to regulatory standards and fulfilling client expectations for...

  • Regulatory Affairs Director

    il y a 1 mois

    Paris, France Proclinical Temps plein

    Proclinical is actively seeking a Regulatory Affairs Director for a part-time role. The successful candidate will be involved in exciting work within the Biologics/ATMP/Gene Therapy industry. This role requires preparing and leading scientific advice meetings, working with the FDA, and focusing on Pre IND activities. Responsibilities:Prepare and lead...

  • Junior Quality Assurance and Regulatory Affairs Associate

    il y a 3 semaines

    Paris, Île-de-France DentalMonitoring Temps plein

    About DentalMonitoringDentalMonitoring is a rapidly expanding MedTech company operating in a dynamic healthcare sector. We are currently seeking a motivated individual for the position of Junior Quality Assurance and Regulatory Affairs Associate.Key Responsibilities✦ Engage in effective communication both internally and externally to inform colleagues and...

  • Regulatory Affairs Specialist

    il y a 16 heures

    Paris, Île-de-France ProductLife Group Temps plein

    We are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group. The ideal candidate will have a strong background in regulatory affairs and experience in managing product registrations in Asia and Sub-Saharan Africa.The Regulatory Affairs Specialist will be responsible for:Developing and implementing regulatory strategies...

  • Regulatory Affairs

    il y a 3 semaines

    Paris, France Meet Temps plein

    Prepare submissions of licence variations, notifications and renewals to strict deadlines Monitor and set timelines for licence variations, notifications and renewal approvals Is responsible for the preparation of Summary of Product Characteristics, Patient Information Leaflets and labelling according to the Quality Review Documents (QRD) format ...

  • Regulatory Affairs

    il y a 2 semaines

    Paris, France Meet Temps plein

    Prepare submissions of licence variations, notifications and renewals to strict deadlines Monitor and set timelines for licence variations, notifications and renewal approvals Is responsible for the preparation of Summary of Product Characteristics, Patient Information Leaflets and labelling according to the Quality Review Documents (QRD) format ...

  • EAME Regulatory Affairs Manager

    il y a 3 semaines

    Paris, Île-de-France International Flavors & Fragrances Inc. Temps plein

    EAME Regulatory Affairs Manager Remote type: Hybrid work Locations: Neuilly-Sur-Seine, France Time type: Full-time Job Overview Are you enthusiastic about the art of fragrance development and the future of scent innovation? We are currently looking for a dedicated and results-oriented professional to join our Scent Regulatory Affairs team. As a ...

  • Associate Director Medical Affairs

    Il y a 3 mois

    Paris, France Regeneron Pharmaceuticals Inc. Temps plein

    Our Associate Director, Medical Affairs, play a pivotal role as a professional with Oncology expertise & Scientific knowledge. We deliver strategic and operational support by establishing, developing, maintaining scientific exchange with medical specialists, health care professionals, and payers. We are looking for our next team member to join our Medical...

  • Regulatory Affairs Specialist

    il y a 3 jours

    Paris, Île-de-France Indegene Temps plein

    Job DescriptionAt Indegene, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Medical Device Consultant, you will play a crucial role in providing expert regulatory advice to our team and ensuring that our clients' projects meet the required standards.Key Responsibilities:Provide guidance on standards pertaining to...

  • Regulatory Affairs Specialist

    il y a 4 jours

    Paris, Île-de-France Indegene Temps plein

    About the RoleIndegene is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for providing expert guidance on regulatory matters related to medical devices in the France market.Key ResponsibilitiesProvide guidance on standards pertaining to advertising and promotion of medical...

  • Regulatory Affairs Expert

    il y a 3 semaines

    Paris, Île-de-France ProductLife Group Temps plein

    Regulatory Affairs Expert We are currently seeking a Regulatory Affairs Expert to play a crucial role in managing regulatory activities within the pharmaceutical sector. This position is vital for ensuring compliance with local and international regulations. Key Responsibilities: Coordinate the gathering of information related to regulatory obligations and...