
International Regulatory Affairs Specialist
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.
- Conduct thorough research and stay up-to-date on international regulations and standards related to medical devices and technology.
- Collaborate with cross-functional teams to ensure all products meet regulatory requirements and are in compliance with international laws.
- Develop and maintain relationships with regulatory agencies and key stakeholders to facilitate the approval process for new products and updates to existing products.
- Prepare and submit regulatory submissions, including premarket notifications, registrations, and product listings.
- Review and approve product labeling and promotional materials to ensure compliance with international regulations.
- Provide guidance and support to internal teams on regulatory compliance matters.
- Monitor and communicate changes in international regulatory requirements to relevant teams and departments.
- Conduct internal audits and provide recommendations for corrective action to maintain compliance with international regulations.
- Act as a liaison between the company and regulatory authorities during inspections or audits.
- Maintain accurate and up-to-date documentation and records related to international regulatory submissions and approvals.
- Participate in cross-functional teams to develop and implement company policies and procedures related to international regulatory compliance.
- Stay informed about industry trends and developments in international regulatory affairs and provide recommendations for continuous improvement.
- Ensure all activities are conducted in accordance with company policies, procedures, and ethical standards.
- Collaborate with global teams to ensure consistency in regulatory processes and procedures.
- Represent the company at international conferences and meetings related to regulatory affairs.
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.
Risk Management
Quality Assurance
Global regulations
Change control
Technical Documentation
Regulatory compliance
Medical Devices
Product Registration
Regulatory Submissions
Labeling Requirements
Post-Market Surveillance
Communication
Conflict Resolution
Leadership
Time management
Interpersonal Skills
creativity
Organizational skills
Teamwork
Adaptability
Problem-Solving
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.
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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.

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