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BD

Regulatory Affairs Specialist

Location:  Salamanca, Spain
Location flexibility:  4 office days / week – Based on location and role requirements.
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Job Description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

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

The Regulatory Affairs Specialist supports global regulatory activities for in vitro diagnostic (IVD) medical devices throughout the product lifecycle. This role is responsible for contributing to regulatory strategy development, regulatory submissions, product registrations, technical documentation, regulatory intelligence, change management assessments, and compliance activities to ensure continued market access worldwide.
The position partners closely with cross-functional teams including Research & Development, Quality Assurance, Manufacturing, Clinical Affairs, Medical Affairs, Operations, and Marketing to ensure regulatory requirements are incorporated into product development, maintenance, and commercialization activities.


The ideal candidate possesses a scientific background, strong analytical skills, and the ability to independently assess regulatory requirements, evaluate regulatory risks, and translate evolving regulatory requirements into actionable business recommendations.

Key Responsibilities

  • Develop, maintain, and support global regulatory strategies for in vitro diagnostic (IVD) devices throughout the product lifecycle.
  • Prepare, review, compile, and maintain regulatory submissions, product registrations, technical documentation, declarations of conformity, and supporting regulatory records to support global market access.
  • Support compliance with applicable global regulatory requirements, including FDA regulations, EU IVDR (EU) 2017/746, UK regulations, Health Canada requirements, and other international regulatory frameworks.
  • Conduct regulatory impact assessments and support change management activities related to product, manufacturing, supplier, software, labeling, design, process, clinical, and post-market changes.
  • Monitor evolving regulations, standards, guidance documents, and regulatory intelligence, and communicate regulatory impacts and recommendations to internal stakeholders.
  • Partner with cross-functional teams including R&D, Clinical Affairs, Quality Assurance, Manufacturing, Medical Affairs, and Marketing to ensure regulatory requirements are incorporated throughout product development and lifecycle management activities.
  • Review product labeling, Instructions for Use (IFUs), promotional materials, and other product-related documentation for regulatory compliance.
  • Support interactions with regulatory authorities, Notified Bodies, Competent Authorities, and other regulatory agencies, including preparation of submissions and responses to regulatory inquiries.
  • Support product lifecycle management activities, including change control assessments, market expansions, performance studies, evidence generation, vigilance reporting, field actions, and regulatory maintenance activities.
  • Support internal and external audits and inspections, maintain regulatory procedures and quality system documentation, and provide regulatory training and guidance to stakeholders.

Required Qualifications

  • Bachelor's degree in Biology, Biotechnology, Biomedical Sciences, Pharmacy, Life Sciences, or a related scientific discipline. Master's degree in Regulatory Affairs, Cell Biology, Health Sciences, Health Administration, Biotechnology will be a plus.
  • 1-3 years of professional experience in Regulatory Affairs, Quality, Medical Devices, IVDs, Life Sciences, or a related field.
  • Strong written and verbal communication skills in English.
  • Ability to interpret and apply technical and regulatory information.
  • Ability to work effectively in a cross-functional and global environment.

Salary range for this role: 27000€ - 29000€

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 Salamanca

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

€26,300.00 - €40,100.00 EUR Annual

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Working at BD

4 office days / week – Based on location and role requirements.

A little flex time – Based on role requirements.

Company benefits

Health insurance
__ days annual leave + bank holidays
Accrued annual leave
Company shutdown periods
Optional unpaid leave
Reservist leave
Buy or sell annual leave
Compassionate leave
Dental coverage
Fertility benefits
Hertility subscription
Mental health pathway
On-site wellness services
Complimentary Medical Services
Eye Care Support
Fertility treatment leave
Men’s health support
Mental health platform access
Personalised nutrition plan
Wellbeing allowance
Women’s health support
Critical Illness Insurance
Family health insurance
Gym membership
Menopause support
Mental health first aiders
Mental health support
Private GP service
Wellbeing incentive programme
Mentoring
Coaching
Learning platform
Further education support
Study support
Professional subscriptions
Collaboration spaces
Bike parking
On-site wellness room
Secure on-site parking
Cycle to work scheme
On-site barista
Private booths
Sensory-Friendly Setup
Chill out zone
Ergonomic workstations
Meditation space
On-site catering
On-site gym
On-site shower
On-site workout classes
Adoption leave
Eldercare services
Shared parental leave
Pregnancy loss leave
Summer holiday childcare
Carer’s leave
Emergency leave
Pregnancy support
401K
Annual pay rises
Equity packages
Salary advance
Additional voluntary pension contribution
Electric Car Salary Sacrifice
Income protection
Life assurance
Salary sacrifice
Nursery salary sacrifice scheme
Annual bonus
Enhanced pension match/contribution
Life insurance
Referral bonus
Share options
Theme park discounts
Cinema discounts
Coffee discounts
Restaurant discounts
Travel insurance
Employee recognition scheme
Career and family coaching
Death in service
Employee discounts
Sabbaticals
Sports teams
Workplace loan
Charity donation scheme
Company wide holidays/offsites
Financial advice
Relocation packages
Teambuilding days
Volunteer days
Car allowance
Company car
Employee assistance programme
Financial coaching
In house training
Neonatal leave
Physiotherapy
Will writing
Modern office
Enhanced maternity leave
Enhanced paternity leave
Tax-free childcare
Women’s health leave
Enhanced maternity leave
Women’s health leave
Non-contributory pension
Religious celebration leave
Bank holiday swaps
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Company employees:

60,000+

Office Locations