Senior International Regulatory Affairs Specialist
BD
Franklin Lakes, New Jersey
Full-Time
$110,200
RemoteSenior
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.
Primary Responsibilities:
Support the registration of medical devices in multiple countries within the LATAM region and Canada by gathering, compiling, evaluating, and preparing documentation for National health authority review.
Evaluate product design dossiers for consistency, congruency, and compliance with registration requirements.
Provide guidance and support to internal stakeholders regarding regulatory requirements and compliance issues.
Collaborate with cross-functional teams such as R&D, marketing, quality assurance, and engineering to ensure timely submission of applications and smooth approval processes.
Develop and implement effective strategies for obtaining approvals in a timely manner while minimizing costs and risks.
Maintain accurate records of regulatory submissions and correspondence with regulators.
Monitor changes in regulations and ensure compliance with all relevant laws and guidelines.
Stay up-to-date with emerging trends in the field of medical device regulation and advocate for policies that promote patient safety and access to innovative technologies.
About You:
High School diploma and 6 years of relevant work experience.
Bachelor’s degree with minimum 2 years of relevant work experience preferred.
At least one year of international regulatory affairs experience preferred, preferably in the medical device industry.
Strong understanding of regulatory frameworks governing medical devices in the LATAM region and Canada.
Excellent communication skills and ability to collaborate effectively across different departments and levels of management.
Ability to manage multiple priorities simultaneously while meeting tight deadlines.
Proven problem solving abilities and attention to detail.
Knowledge of ISO standards related to medical devices.
Experience working with international organizations is advantageous.
Proficiency in Microsoft Office Suite including Word, Excel, PowerPoint, Outlook, etc.
High level of proficiency using SAP at several levels. Experience with Master Control is advantageous.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
At BD, we are committed to supporting our associates’ well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:
Annual Bonus
Health and Well-being Benefits
Medical coverage, Health Savings Accounts, Flexible Spending Accounts, Dental coverage, Vision coverage, Hospital Care Insurance, Critical Illness Insurance, Accidental Injury Insurance, Life and AD&D insurance, Short-term disability coverage, Long-term disability insurance, Long-term care with life insurance.
Other Well-being Resources
Anxiety management program, wellness incentives, sleep improvement program, diabetes management program, virtual physical therapy, emotional/mental health support programs, weight management programs, gastrointestinal health program, substance use management program, musculoskeletal surgery, cancer treatment, and bariatric surgery benefit.
Retirement and Financial Well-being
BD 401(k) Plan, BD Deferred Compensation and Restoration Plan, 529 College Savings Plan, financial counseling, Baxter Credit Union (BCU), Daily Pay, college financialaidand application guidance.
Life Balance Programs
Paid time off (PTO), including all required State leaves, educational assistance/tuition reimbursement, MetLife Legal Plan, group auto and home insurance, pet insurance, commuter benefits, discounts on products and services, Academic Achievement Scholarship, Service Recognition Awards, employer matching donation, workplace accommodations.
Other Life Balance Programs
Adoptionassistance, backup day care and eldercare, support for neurodivergent adults, children, and caregivers, caregivingassistancefor elderly and special needs individuals, Employee Assistance Program (EAP), paid parental leave, support for fertility, birthing, postpartum, and age-related hormonal changes.
Leave Programs
Bereavement leaves, Military leave, Personal leave, Family and Medical Leave (FML),Juryand Witness Duty Leave.
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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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
$110,200.00 - $176,400.00 USD Annual