Becton Dickinson

International Regulatory Affairs Specialist

Becton Dickinson

28750 San Agustín del Guadalix, Madrid, Spain
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Welcome to Becton Dickinson, a global leader in medical technology that is dedicated to improving the health and well-being of people around the world. We are currently seeking an ambitious and highly motivated International Regulatory Affairs Specialist to join our team. As an International Regulatory Affairs Specialist at Becton Dickinson, you will play a crucial role in ensuring our products comply with international regulations and standards, allowing us to provide safe and effective medical solutions to patients worldwide. We are looking for a detail-oriented individual with a strong understanding of regulatory requirements, excellent communication skills, and a passion for making a difference in the healthcare industry. If you are ready to take on this challenging and rewarding role, we encourage you to apply today.

  1. Conduct thorough research and stay up-to-date on international regulations and standards related to medical devices and technology.
  2. Collaborate with cross-functional teams to ensure all products meet regulatory requirements and are in compliance with international laws.
  3. Develop and maintain relationships with regulatory agencies and key stakeholders to facilitate the approval process for new products and updates to existing products.
  4. Prepare and submit regulatory submissions, including premarket notifications, registrations, and product listings.
  5. Review and approve product labeling and promotional materials to ensure compliance with international regulations.
  6. Provide guidance and support to internal teams on regulatory compliance matters.
  7. Monitor and communicate changes in international regulatory requirements to relevant teams and departments.
  8. Conduct internal audits and provide recommendations for corrective action to maintain compliance with international regulations.
  9. Act as a liaison between the company and regulatory authorities during inspections or audits.
  10. Maintain accurate and up-to-date documentation and records related to international regulatory submissions and approvals.
  11. Participate in cross-functional teams to develop and implement company policies and procedures related to international regulatory compliance.
  12. Stay informed about industry trends and developments in international regulatory affairs and provide recommendations for continuous improvement.
  13. Ensure all activities are conducted in accordance with company policies, procedures, and ethical standards.
  14. Collaborate with global teams to ensure consistency in regulatory processes and procedures.
  15. Represent the company at international conferences and meetings related to regulatory affairs.
Where is this job?
This job is located at 28750 San Agustín del Guadalix, Madrid, Spain
Job Qualifications
  • Bachelor's Or Master's Degree In A Relevant Field Such As Regulatory Affairs, Pharmacy, Biology, Or Chemistry

  • Minimum Of 3-5 Years Of Experience In International Regulatory Affairs Within The Medical Device Industry

  • In-Depth Knowledge Of Global Regulatory Requirements And Standards, Including Fda, Eu Mdr, And Iso 13485

  • Experience With Product Registration And Submission Processes In Multiple Countries, Including Asia, Europe, And Latin America

  • Strong Analytical And Problem-Solving Skills, With The Ability To Interpret And Apply Complex Regulations And Guidelines To Product Development And Commercialization Strategies.

Required Skills
  • Risk Management

  • Quality Assurance

  • Global regulations

  • Change control

  • Technical Documentation

  • Regulatory compliance

  • Medical Devices

  • Product Registration

  • Regulatory Submissions

  • Labeling Requirements

  • Post-Market Surveillance

Soft Skills
  • Communication

  • Conflict Resolution

  • Leadership

  • Time management

  • Interpersonal Skills

  • creativity

  • Organizational skills

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a International Regulatory Affairs Specialist in 28750 San Agustín del Guadalix, Madrid, Spain is between €35,000 to €50,000 per year. However, this can vary depending on the specific company, experience level, and other factors. It is best to research the specific job posting or company to get a more accurate salary range.

Additional Information
Becton Dickinson is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesSpanish
Job PostedMarch 14th, 2025
Apply BeforeMay 22nd, 2025
This job posting is from a verified source. 

Apply with Video Cover Letter Add a warm greeting to your application and stand out!

About Becton Dickinson

The BD Life Sciences segment delivers innovative solutions from discovery to diagnosis, continually advancing science and clinical outcomes across infectious disease and cancer. Offerings include preanalytical solutions for sample management, immunology research solutions, including flow cytometry and multiomics tools, microbiology and molecular diagnostics, lab automation and informatics solutions, as well as differentiated reagents and assays.

Frequently asked questions

Get interviewed today!

JobzMall is the world‘ s largest video talent marketplace.It‘s ultrafast, fun, and human.

Get Started