Senior International Regulatory Affairs Specialist

Job description

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 DescriptionResponsibilities: 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 planReviews 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 ExperienceBachelor'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 ExpertiseMaintained 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 LeadershipExercised 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 TeamworkCollaborated 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 ContinuouslyDrove 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 ClearlyCommunicated 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-related hormonal changes Leave Programs Bereavement leaves Military leave Personal leave Family and Medical Leave (FML) Jury and Witness D