Job Description Summary

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 acquire 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.

Job Description

--We are the makers of possible--

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

--Why join us?--

A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.

Become amaker of possiblewith us!

--Our vision for “Regulatory Affairs” at BD--

The Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset.

-About the role

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 acquire 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.

-Main responsibilities will include:

• 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.

-About you

• At least 3 years experience in regulatory affairs within the medical devices technology industry.
• Compliance experience with Class I/IIa/III products under MDD/MDR.
• Have knowledge of the regulatory framework pertaining to Medical Devices such as the MDD and MDR CE Marking.
• Experience with NB communications.
• 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.
• Proven 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.

Click on apply if this sounds like you!

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

To learn more about BD visit:https://bd.com/careers

Primary Work Location

ESP San Agustin del Guadalix

Additional Locations

Work Shift