Regulatory Affairs Specialist

Now

Job ID

R-555625

Category

Regulatory Affairs

Location

San Agustín del Guadalix, Spain

Region

EMEA

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

Being a key strategic partner for the EMEA BD Business by (i) supporting the implementation of registration strategies for the BD portfolios, 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).

Main responsabilities will include:

• 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 and support their submissions to Regulatory Agencies by interacting with Country RA to ensure a faster time to market align with the registration/renewal objectives approved by eIPPRA.
• Lead the Registration planning and prioritization in EMEA to drive alignment with the Business.
• Execute on product launches, renewals, amendments due to products changes and regulatory re-registrations due to new local regulations/requirements of existing BD products already registered in the EMEA region in accordance with the RA planning and priorities defined in collaboration with the EMEA Marketing Team and approved by eIPPRA
• Conduct Impact Assessments for Product changes and Regulation changes in EMEA to ensure compliance with Regulations
• Release BD products 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 up to date
• Lead and/or represent the EMEA RA team by joining project teams to anticipate regulatory risks, support the development and the implementation of mitigation strategies and processes within the EMEA region.
• Follow regulatory developments within the EMEA region and share knowledge of EU regulatory requirements for Medical Devices which may impact the BD Business in EMEA
• Provide other duties and assignments as required

Education and Experience:

• Preferably with scientific educational background
• 3 to 5 years of experience in the Regulatory Affairs, preferably in the Medical field with International experience.

Knowledge and Skills:

• Organizational and planning skills, including action oriented, focused urgency, and driving for results
• Ability to juggle multiple tasks and to prioritize and schedule work to meet business needs
• Analytical problem solving
• Excellent written and verbal communication skills including ability to communicate across culture; work with others in team environment; and effective interactions with technical personnel (scientific and legal)
• Ability to work in an international environment
• Native level English proficiency, both written and verbal
• Orientation for detail work product, with emphasis on accuracy and completeness
• Promotes a collaborative environment and removes obstacles to teamwork across the organization
• Computer literate

Salary range for this role: EUR 36.000 - 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

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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