A superb, wide-ranging Regulatory Affairs career development role with BD, a global leader in Medical Technology.
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 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’.
At BD we are developing a project for new products in the plant located in Almaraz. As part of the Project Management team and following the Project leader guidelines, the Regulatory Affairs Specialist will execute the registration, documentation, and all other necessary tasks related to medical device requirements in different markets. Also, as part of the team, the Regulatory Affairs Specialist will support and collaborate in other tasks needed to perform document compliance activities with the current and upcoming EU medical device regulation.
The Regulatory Affairs Specialist is a position created under the umbrella of the Quality Department, reporting to the Quality Manager, which main responsibility is to represent represent regulatory affairs within Sendal Almaraz facility new product development, sustaining engineering and other product development initiatives for CE marked medical devices (Class Is and IIa) and will support worldwide registrations. The Regulatory Affairs Specialist is the main executor of Regulatory tasks and also Quality Engineering in some cases for medical products. The person should work independently with a minimum supervision and to have a proactive attitude solving problems. The Regulatory Affairs Specialist primary will work with cross-functional teams to providing Regulatory guidance and support for disposable products distributed by BD. Other key Regulagtory Specialist responsibilities include:
- Support registration activities for CE marked products and develop and maintain Intercompany regulatory communication and relationships.
- Report to Quality Manager with dotted line to Senior RA Manager and provide weekly report to Senior RA Manager, Winnersh and escalate challenges in a timely manner.
- Verify that post-marketing monitoring obligations are met in accordance with the regulations/standards.
- Knowledge of GMP (Good Manufacturing Practices) and Regulatory requirements for the medical industry.
- Desirable knowledge of ISO13485
- Advanced level of English (minimum B2, desirable C1)
- Experience working with cross-functional teams in multiple locations with high sense of urgency and execution focus
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Primary Work Location ESP Almaraz - Ctra. Nacional