Senior International Regulatory Affairs Specialist





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Job Description

Responsibilities:

The Senior International Regulatory Affairs Specialist will be responsible for partnering in the preparation and approval of regulatory submissions of medical devices worldwide.

Job Responsibilities:

• •Leads collecting, compiling, and analyzing, country specific regulatory requirements
• •Drives international registrations according to project plan
• •Reviews and approves technical documentation to ensure required information and data for regulatory submissions are included.
• •Prepares and/or compiles information required by international regulatory associates to register or maintain registration of products in international regions.
• •Collaborates with cross-functional teams for preparation of additional data/information requested by notified body/ regulatory agencies and prepares appropriate responses to all requests.

• •Navigates, interprets, and applies Design History File (DHF)/Technical File (STED) content to assess regional applicability and support international regulatory submissions.
• •Develops and executes regulatory strategies for product registrations, renewals, and lifecycle changes to support business objectives and market access requirements.
• •Proactively identifies regulatory risks, assesses potential business impact, develops mitigation plans, and escalates critical issues in a timely manner to enable effective decision-making and maintain project timelines.
• •Navigates and works effectively across multiple quality management systems, regulatory processes, and regional requirements to ensure timely execution of registrations
• •Ensures submission tasks related to Change Control are completed
• •Compiles and communicates Regulatory impact assessments, submission & approval status world-wide to Supply Chain to ensure regulatory compliance and business continuity
• •Obtains Regulatory Certificates such as CFGs and FSCs
• •Generate and coordinate responses to regulatory authority questions and deficiency letters in collaboration with internal subject matter experts.
• •Support global product lifecycle activities, including renewals, labeling updates, and change assessments, ensuring ongoing compliance in assigned markets.

Education and Experience:

• •Required Education and Experience
• •Bachelor's degree in health science, life science, biology, chemistry, bio-engineering, microbiology, or a related field.
• •Minimum 6 years of experience in the medical device industry
• •Experience with international regulatory product registrations and assessments across multiple regions, such as CASAJ, Greater China, LATAM, Canada, and EMEA.
• •Working knowledge of STED, technical files, design dossiers, and required submission structure and content.
• •Digital literacy with regulatory, quality, and business systems/tools such as SAP, MasterControl, JDE, and Microsoft tools.
• •Microsoft Office Proficiency( AI Copilot, Agent, Word, Excel, PowerPoint, PowerBi)
• •Experience navigating Design History File (DHF) and reviewing Design Verification reports to support regulatory assessments, registrations, submissions, or product changes

• •Technical Expertise
• •Maintained regulatory documentation, records, and tracking systems.
• •Evaluated product changes, post-market impacts, and regulatory risks to support market access.
• •Prepared regulatory submissions, assessed requirements, and ensured compliance with applicable regulations and standards.
• •Developed regulatory strategies and submission pathways for global registrations and lifecycle management activities.

In addition to technical expertise, the position requires the following core professional competencies and soft skills:

• •Decisive Leadership
• •Exercised sound regulatory judgment and managed competing priorities to achieve regulatory objectives.
• •Identified risks, assessed impacts, and provided recommendations to support business decisions.
• •Communicated regulatory strategies, issues, and potential impacts to stakeholders and leadership.

• •Foster Teamwork
• •Collaborated effectively with regional, cross-functional, and business partners to deliver regulatory outcomes.
• •Built strong working relationships and supported a collaborative team environment.
• •Coordinated activities and communicated proactively to ensure successful execution of deliverables.

• •Improve Continuously
• •Drove improvements in regulatory processes, submission quality, compliance, and operational efficiency.
• •Expanded regulatory knowledge and applied best practices to support continuous improvement.
• •Adapted to feedback and maintained high-quality execution under tight deadlines.

• •Communicate Clearly
• •Communicated complex regulatory information clearly to technical and non-technical audiences.
• •Delivered concise status updates, presentations, and regulatory recommendations.
• •Facilitated alignment through effective listening, documentation, and stakeholder engagement.

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.

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 financial aid and 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

Adoption assistance

Backup day care and eldercare

Support for neurodivergent adults, children, and caregivers

Caregiving assistance for elderly and special needs individuals

Employee Assistance Program (EAP)

Paid Parental Leave

Support for fertility, birthing, postpartum, and age-relat