Senior Regulatory Affairs Specialist
Job Description Summary
BD is a global medical devices technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases. BD provides an environment which enables our highly talented workforce to be the best at their professions. We are always seeking people who have a passion and commitment to join our Company on its journey to ‘helping all people live healthy lives’.
The Regulatory Affairs Specialist Senior has to gain department and platform influence by co-operating in all RA accomplishments and sharing regulatory knowledge of demonstrating compliance with changing global regulations, also identifying, preparing and collecting data needed to obtain and maintain certifications and commercialization authorizations of BD products. The function is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured and distributed to meet applicable regulatory requirements and applicable technical standards. Some of the responsibilities would be:
- Participation in cross-functional product development teams as the regulatory lead.
- Development of regulatory strategies for product release and product change assessments.
- Participate to the review of process/product changes, labeling, claims, product complaints, etc., to determine the need for any regulatory activities and to ensure compliance to Medical Devices regulations;
- Attends to audits performed by internal and external authorities to represent RA positions and processes;
- Execute transition of MDD tech files to MDR Technical Documents, monitor and report progress
- OUS international product registrations attending to individual country specific requirements; monitor and report progress
- Assesses changes in regulations and helps to determine their impact;
- Prepare regulatory dossiers for submission to Health Authorities and maintains them along the whole product life-cycle.
We are looking for someone with proven regulatory affairs experience within the medical devices technology industry or equivalent. You should have demonstrated compliance experience with Class I/IIa/III products under MDD/MDR. In addition you should:
- Have knowledge of the regulatory framework pertaining to Medical Devices such as the MDD and MDR CE Marking;
- Experience with NB communications (AEMPS preferred)
- Experience working with International Standards in particular ISO 7864, ISO 7886, ISO 6009, ISO 9626, 62366(usability), ISO 14971 and ISO 13485; Good working knowledge of Design Control, Risk Mgmt, V&V processes;
- Prior work experience on MDR preferred;
- Solid knowledge and material experience in International registrations/ approval process for medical devices.
You should be an enthusiastic teammate, able to participate with commitment and sense of ownership in highly qualified teams, in a complex and fast evolving environment. With Strong knowledge in international standards and regulations including MDD, MDR, ISO 13485.
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? Register on our careers page so you never miss an opportunity. http://emea.jobs.bd.com/
Primary Work LocationESP San Agustin del Guadalix
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