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 commercialization authorizations of BD products and support tenders in Spain and Portugal. 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. Some of the responsibilities would be:
- Development of regulatory strategies for product release and product change assessments.
- National communications to Portugal and Spain related to class IIa, IIb, III, Annex II products to allow products commercialization;
- Promotional material review and approval;
- Assesses changes in regulations and helps to determine their impact;
- Compliance with WEEE and batteries regulation;
- Review and approval of marketing technical data sheet;
- Support to marketing services, customer services and tenders request;
- Communications with authorities (Spanish and Portuguese).
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 MD and IVD under MDD/IVD and knowledge about new IVDR / MDR. In addition, you should:
- Have knowledge of the regulatory framework pertaining to Medical Devices such as the MDD and MDR CE Marking;
- Prior work experience on MDR preferred;
- Solid knowledge and material experience in national communications within EU market
- International registrations/ approval process for medical devices.
- Contacts within the competent authorities, preferably in Spain and Portugal
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, IVD, MDR, IVDR, National laws related to Medical and In Vitro devices.
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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