BD (Becton, Dickinson and Company) RA Project Manager in Wexford, Ireland
Job Description Summary
BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. BD provides an environment which enables our highly talented workforce to be the best in their professions. We are always seeking people who have a passion and commitment to join our Company on its journey in ‘advancing the world of health’.
At the Enniscorthy facility, we manufacture mainly angioplasty catheters that are used in both coronary and peripheral procedures to unblock arteries. We are now recruiting a RA Project Manager (Permanent Role).
Reporting to the Senior Manager Regulatory Affairs, you will be responsible and accountable for regulatory support, with a primary focus on UDI, for operations, product development and quality to ensure that the product is in compliance with all internal and external regulatory requirements. You will be a key member of the RA team. The role requires a high level of ownership and enthusiasm.
Your responsibilities will include:
Regulatory Affairs Subject Matter Expert on UDI / EUDAMED / GUDID requirements globally (e.g. MDR UDI, US UDI, China UDI, EUDAMED, GUDID, etc.);
Implement and maintain global UDI /EUDAMED / GUDID requirements and associated procedures for two company sites (Ireland & Germany) in accordance with the company wide UDI / EUDAMED / GUDID initiatives;
Train Regulatory Affairs & Quality System team members on UDI / EUDAMED /GUDID processes and systems;
Assist in the development and improvement of Regulatory processes and procedures and in the harmonization of processes within the Global RA Team;
Reviews Engineering Change Orders, Design Change Notices and other deviations to assess impact to UDI;
Participates in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements;
Understand and follow company procedures on regulatory requirements;
Provide positive example and actively promote compliance to all standards;
Maintain a professional working relationship with internal and external customer and support staff;
Prepare and present project updates and technical discussions.
The successful candidate will have solid educational background with a degree in Science or Engineering or relevant scientific discipline with work experience in Regulatory Affairs and/or Quality Systems, preferably in the Medical Device or Pharmaceutical industry. You will have good regulatory knowledge, e.g. guidelines, policies, principles and requirements of applicable product laws/standards.
The ideal candidate will have knowledge in CE marking according to MDR; EUDAMED attribute data & UDI requirements and implementation and labelling procedures.
You will have the ability for strong attention to detail in a complex work environment with multiple and competing registration priorities. Good planning and organizational skills. German knowledge is an advantage.
To ensure the safety of our associates, BD supports remote work where possible. This position is based in Enniscorthy but is temporarily remote-based due to Covid-19. We are continuing to monitor the situation and follow local governmental guidance to advise when is the right time and safe for our associates to return to their BD work location.
You can look forward to a rewarding career, great benefits package, collaborative working and opportunities to expand your skills in this fast moving, dynamic and agile business.
If you’re a team player who is passionate about healthcare and we’ve just described 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://emea.jobs.bd.com
Primary Work Location
IRL Wexford - Enniscorthy
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.