BD (Becton, Dickinson and Company) Regulatory Affairs specialist EU - BD PAS in Erembodegem, Belgium
Job Description Summary
The Regulatory Affairs Specialist PAS, EU, is reporting directly to the RA Manager, Regulatory Affairs EU and is part of the RA EMEA BD Life Sciences department and the RA EU team BD Life Sciences. This position will mainly focus on providing regulatory support for BD PAS products in Europe/CEE and Israel in relation to the new MDR and IVDR regulation.In addition, any regulatory activity due to the Brexit will be closely monitored and followed up with the appropriate stakeholders.
Key responsibilities include, but are not limited to
Processes regulatory requests in relation to product registration or tender requirements for BD PAS products in EU/CEE and Israel and provides responses in a timely manner. Where applicable, requests are to be made through the applicable (i.e. eGPS) system;
Coordinates timely preparation of requests for Certificates to Foreign Government, Certificates of Manufacture and Free Sale and Certificates of Exportability. Interfaces hereto with applicable regulatory organization within BD or regulatory agencies directly;
Interfaces with OEM's to collect specific registration information as needed;
Maintains the EU CE-databases;
Coordinates and supports the provision of a variety of statements to help the business;
Reviews and responds to internal and external customer requests for regulatory documents;
Follows up on all required translations for labels and IFUs for the EU region;
Develops and maintains departmental procedures (SOP's and work instructions) for European and international product registrations (CEE and Israel) and/or regulatory activities as needed;
Has a good understanding or desires to obtain knowledge of EU regulatory requirements for in vitro diagnostic medical devices and medical devices which may impact the BD PAS Business;
Recognizes and proposes continuous process improvements.
Manages small projects individually and provide support to other projects as appropriate.
Provide other duties and assignments as required.
More about yourself:
Structured and self-organized, your strong planning, time management and prioritization skills are recognized, including your ability to multitask. Other skills include:
Demonstrated self-starter, and highly motivated.
Demonstrated analytical problem solving.
Demonstrated ability to juggle multiple tasks and to prioritize and schedule work to meet business needs.
Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results
Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; and effective interactions with technical personnel (scientific and legal).
Orientation for detail work product, with emphasis on accuracy and completeness.
Promotes a collaborative environment and removes obstacles to teamwork across the organization
Ability to work in an international environment
Travel: International travel up to 10%
Education: Related degree level education required. Higher education is a plus.
Licenses/Certifications: Industry/function specific certification preferred.
Experience: 1-2 years or more related industry (e.g. life sciences) experience preferred.
Competencies: Native level English proficiency, both written and verbal. Additional EU language is a plus. Computer literate.
If you are interested, please click the "Apply" button!
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.