BD (Becton, Dickinson and Company) Regulatory Compliance Specialist - Fixed term in Erembodegem, Belgium
Job Description Summary
This role has the following responsibilities:
Handling complaint and vigilance reporting activities in accordance with Regional and local regulatory requirements, including review and submission of Vigilance Reports to the local Competent Authority, management of field actions, communications with customers and Regulatory Authorities and collaboration with EU compliance functions.
Liaising with the local Competent Authorities and managing the relationship with them and deal with any specific queries relating to post-market activities and issues.
Participating with local trade associations and working groups to secure industry position on devices subject to product & reimbursement compliance in collaboration with marketing and sales departments.
Preparing documentation required in relation to any planned post-market registries. Managing and executing compliance requirements in accordance with internal procedures
Managing local compliance with requirements relating to Environmental (WEEE Directive /Batteries Directive …) in collaboration with other departments.
Managing activities needed to meet local Agency requirements relating to post-market clinical investigations, evaluations or registries.
Managing local processes required to support the business, in relation to product samples, consignment stock and returns to ensure compliance in accordance with internal policies and procedures.
Managing local Competent Authority inspections of national entities and ensuring appropriate engagement with local, European and Corporate leadership.
Knowledgeable about EU MDR and IVD
Additional responsibilities include:
Providing metrics, reports and assistance as required by management.
Liaising with internal and external customers as required, including local distributors, Agents and BD / Bard Suppliers.
Provide training to staff as required, ensuring BD / Bard remain in compliance with established quality and regulatory requirements.
Strong analytical skills
Interpersonal, communication and team working skills. This role will require active communication across all levels of the organization, including with sales and marketing, hospitals, and regulatory agencies.
Effective written and verbal communication.
Ethical behaviour at all times.
Solid understanding of post-market surveillance requirements under the Medical Devices regulation
Three or more years’ experience in the medical device industry, including in-depth knowledge of CE marking requirements.
Demonstrated experience working with competent authorities and participating in trade association working groups.
Degree educated – in a scientific or related subject with medical or pharmacy experience.
Ideally with further academic or professional qualifications specific to the medical device industry.
The candidate must be fluent in English. Fluency in any additional languages is also considered beneficial but not essential.
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Primary Work Location
BEL Erembodegem - Dorp 86
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.