BD (Becton, Dickinson and Company) Regulatory Affairs Lead - France & Benelux in Parkile, France
Job Description Summary
Reporting to the Director Regulatory Affairs EU, the successful candidate will be responsible for managing all
regulatory activities required to support the business. This includes activities relating to product notifications,
MDR Compliance, promotional material review, new product introductions, implementation and maintenance of
RA procedures in order to comply with company policies and procedures as well as EU and local regulations and
standards, including EU MDD 93/42/EEC. assist in MDR activities for France and across EU.
The Difference of One
We are currently recruiting for A new and exciting opportunity for the position of Regulatory Affairs Lead for the France & Benelux business regions, based in Voisins-le-Bretonneux (Paris Region).
Reporting to the Director Regulatory Affairs EU, you will be responsible for managing all regulatory activities required to support the business. This includes activities relating to product notifications, MDR Compliance, promotional material review, new product introductions, ntenance in order to comply with company policies and procedures as well as EU and local regulations and standards, including EU MDD 93/42/EEC and ISO 13485/9001. The position will represent Regulatory Affairs and Quality as part of the local Management Board.
Your main responsibilities
Support local product launch and business activities to secure timely market access by making and maintaining the required product notifications; ensure products placed on the market are in accordance with national laws.
Implement Bard Corporate and European procedures and processes including Quality Management System reviews, as appropriate; to support the RA organization.
Ability to assist in BD compliance to the Medical Device Regulation in France and the wider EU as required.
Be the direct contact for the Trade Association and Competent Authorities and manage the relationship with them and deal with any specific queries relating to regulatory activities.
As necessary, and in collaboration with clinical, marketing and sales departments, support tender applications as well as reimbursement activities and reimbursement requests for applicable product categories.
Approve all locally generated promotional and advertising material to ensure compliance with national laws, BD policy and procedures.
Prepare documentation required in relation to any planned clinical investigations.
Participate in local working groups, including monitoring and communication of regulatory developments and changes in requirements to RA Leadership.
Ensure compliance with regulatory requirements relating to service and repair for any Bard capital equipment placed on the market.
Execute regulatory requirements in accordance with Bard procedures covering the Item Master creation and International Regulatory Release (IRR) processes.
Represent BD interests in local and International standards bodies to help support the Corporate position on key standards.
Liaise with the Product stewardship team to ensure compliance with applicable requirements relating to Environmental Health and Safety (EHS) requirements (WEEE Directive/Batteries Directive/Packaging and Packaging Waste Directive).
Oversee regulatory activities needed to meet local Regulatory Agency requirements relating to post-market clinical investigations, evaluations or registries; provide notifications and reports to the local Regulatory Agency where required.
Manage any local Regulatory Authority inspections and ensure appropriate engagement with local, regional, Divisional and Corporate leadership.
Generate and provide metrics, reports and assistance to the businesses and functions as required.
Liaise with internal and external customers as required, including local distributors, Agents and Non Bard Suppliers.
Provide training to local staff as required, ensuring Bard remains in compliance with established quality and regulatory requirements.
Manage RA personnel as required by the business
Who you are
The ideal candidate will possess a B.S. in a scientific discipline with a minimum of 5 years of experience in a regulated health industry, with a concentration in medical devices preferred. Qualified candidates must have a strong working knowledge of EU regulatory affairs, Quality Management Systems, and local country requirements in addition to demonstrated experience working with competent authorities / regulatory agencies.
Good working knowledge of Medical Devices Directive 93/42/EEC and Quality Management System requirements, in particular ISO 13485 and ISO 9001.
Strong relationship building skills; demonstrated leadership coupled with the ability to work well with people at all levels and in all functions of the organization as well as with external regulatory agencies.
Good analytical skills; attention to detail and ability to manage multiple tasks and priorities at the same time.
Excellent communications, technical and presentation skills.
Computer skills (Advanced with Microsoft Excel, Word, Outlook and PowerPoint).
Fluent in French, ability to read and speak English; working knowledge other European languages helpful.
What we offer you
As the Regulatory Affairs Lead France & Benelux, you will be in charge of a challenging and a worldwide perimeter working on different projects in link with different products with a high added value.
If you are looking for an opportunity where there's a lot to create in an autonomous environement, then this position is made for you!
If this describes you and your career aspirations, then please click on the APPLY button.
Interested in a career with BD, but this position doesn’t fit your skills and experience? Join our external EMEA Talent Community here: http://bd.tal3nt.community/
Decouvrez BD, Visit and learn more about BD
Primary Work Location
FRA Le Pont-de-Claix Cedex
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.