Job Description Summary As Regulatory Affairs Specialist, you will support manufacturer activities including change control projects, NB interactions, audit support in RA role, international registration activity, and manufacturing site support.
About BD BD is one of the largest global medical technology companies in the world.
Advancing the world of health is our Purpose, and 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.
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.
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 a patient-centric mindset.
About the role As Regulatory Affairs Specialist, you will support manufacturer activities including change control projects, NB interactions, audit support in RA role, international registration activity, and manufacturing site support.
The Regulatory Affairs Specialist must contact local RA to get information about BU requirements related to international registration activities to maintain certification and commercialization authorizations of BD products.
Main responsibilities will include: CE mark certificate activities.
Technical documentation (creation and maintenance).
International Registration activities (WW), including the preparation of regulatory dossiers to submit to Health Authorities, conduct legalization process, and set registration strategies.
Leading change control projects in RA role to be implemented in manufacturing sites.
Standard assessment related to compliance determination about product design and production process.
Audit support: manufacturer and manufacturing sites.
Communication with Spanish CA on manufacturer responsibilities located in Spain.
NB communications: audits, change control submissions, vigilance process, certificates affairs.
About you Experience in regulatory affairs within the medical devices technology industry.
Compliance experience with Class I/IIa/III products under MDR.
Knowledge of the regulatory framework pertaining to Medical Devices (MDR is required).
Experience with NB communications.
Experience working with International Standards and regulations including MDD, MDR, ISO 13485.
Proven knowledge and material experience in International registrations/approval process for medical devices.
MDSAP knowledge is a plus.
Proficiency in English.
Enthusiastic teammate, able to participate with dedication and 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.
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