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Regulatory Affairs Specialist Specimen Management EMEA

BD -
San Agustín de Guadalix, Madrid provincia

Solicitar ahora

Detalles del empleo

De 32.700 € a 52.350 € al año
Hace 10 días

Descripción completa del empleo

Now

Job ID

R-551448

We are the people who give possibilities purpose

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.

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.

About the role

Being a key strategic partner for the EMEA BD Business by (i) supporting the implementation of registration/regulatory strategies for the BD SM portfolio, closely aligned with the region's commercial objectives, to meet EMEA market requirements and (ii) securing local markets by maintaining local licenses compliant with changes related to local/global regulations or changes to the product(s).

This role may also involve reviewing and approving promotional material, managing regulatory and product related documentation, providing local regulatory support, and participating in projects. The Regulatory Specialist works closely with cross-functional teams to support business initiatives and offer subject matter expertise on EMEA legislation and standards.

Main responsibilities will include:

The main activities of this role includes but are not limited to:

Navigate within the BD matrix organization to ensure a close alignment between the Region regulatory strategies and Business Unit (BU) and Country Regulatory Affairs (RA) teams’ objectives
Assemble technical information, by interacting with BU RA as necessary, to create Registration and/or Notification Dossiers in compliance with local requirements. Support regulatory submissions to Regulatory Agencies as appropriate by collaborating with Country RA to ensure a faster time to market and align with the registration/renewal objectives approved by eIPPRA.
Execute on product launch plan, upcoming renewals and amendments of registration licenses due to products changes and regulatory re-registrations of new local regulations/requirements of existing BD products already registered in the EMEA region. Execution in accordance with the Registration planning and prioritizations defined in close collaboration with the EMEA Marketing Team and supported by approved eIPPRA submissions.
Conduct Impact Assessments for Product changes and Regulation changes in EMEA to ensure continued compliance with Regulations
Release BD products to the market in compliance with their country registration status in EMEA
Ensure Regulatory Information Management (RIM) system, internal EMEA Registration databases and specific project trackers related to the RA activities are maintained and up-to-date
Address product-specific regulatory queries from local teams to support market access and compliance
Provide other duties and assignments as required.

Salary range for this role: EUR 35,000 - EUR 40,000

Why Join Us?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

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

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.

Required Skills

Optional Skills

Primary Work Location

ESP San Agustin del Guadalix

Additional Locations

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You."

Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed.

Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

€32,700.00 - €52,350.00 EUR Annual

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