Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
As Senior Regulatory Affairs Specialist you will be responsible for ensuring that our MD /IVD comply with EU/ National (Spain and Portugal) regulations about the Go to Market activity. You'll work closely with quality, sales, regulatory, tender and marketing teams to ensure our products are brought to market in a safe and timely manner.Job Description
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.
Main responsibilities will include:
Prepare and submit product registration applications to the Spanish and Portuguese health authorities.
Stay up-to-date on national and international regulations applicable to Medical Device /IVD.
Provide advice and support to quality, sales, tender, customer service and marketing teams on regulatory matters.
Conduct AdProm material revision according to National (Spain and Portugal) regulations.
Participate in regulatory / quality audits.
Collaborate with other BD departments to ensure compliance with regulations.
About you
Bachelor's degree in Pharmacy, Biology, Chemistry or a related field.
Experience in Medical Device / IVD sector with in-depth knowledge of regulations in Go to Market area.
Excellent written and oral communication skills in Spanish and English.
Ability to work independently and as part of a team.
Ability to manage multiple tasks and meet deadlines.
Click on apply if this sounds like you!
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!
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
Required Skills
Optional Skills
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Primary Work Location
ESP San Agustin del GuadalixAdditional Locations
Work Shift
Success Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.