BD (Becton, Dickinson and Company) Senior International Regulatory Affairs Specialist (remote) in Franklin Lakes, New Jersey

Job Description SummaryExcited to grow your career? Our people make all the difference in our success. Our Regulatory Affairs team is helping to ensure speed to market for BD’s innovative medical technologies by having an acutely patient-centric mindset. AsSenior International Regulatory Affairs Specialist, you will be primarily focused on maintaining continued international market access, providing regulatory support for new product development projects and executing regulatory deliverables to align with project timelines, to manage the processes and systems designed to ensure that all applicable regulatory compliance requirements are met.TheSenior International Regulatory Affairs Specialist within the BD’s innovative medical technologies is responsible for partnering in the preparation and approval of regulatory submissions of medical devices worldwide. Under the mentorship of the Manager of Regulatory Affairs, they are responsible for the development of complex global regulatory strategies and preparation of regulatory submissions required to market medical devices in countries around the world. TheSenior RA Specialist will also support related regulatory affairs activities, such as development, execution and management of procedures and systems to ensure that the product development process – including clinical studies and strategy – addresses all regulatory requirements and objectives of the business.The incumbent will perform essential duties and responsibilities with minimal direction while providing mentorship to more junior regulatory associates. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics allowing you to broaden your expertise and grow in your career. This role provides the opportunity to work remotely. Job DescriptionWe are the makers of possibleBD 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. We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us. Key responsibilities will include:• Lead development and execution of global regulatory strategies by collaborating closely with international regulatory associates to prepare submissions to register devices worldwide.Address and resolve requests for additional information. • Collaborate with international regulatory associates to assess necessity for reporting changes to global regulatory authorities for device modifications. • Identify and communicate appropriately quantified risks and mitigations associated with global regulatory strategies to cross-functional collaborators. • Represents RA and demonstrates leadership in product development team(s). Responsible for completion of regulatory strategies, review and approval of design control-related documents.• Provide cross-functional support for regulatory submissions and compliance, including approval of product labeling, promotional, and advertising materials; and writing/updating standard operating procedures, work instructions, and policies. • Coordinate and prepare technical files for submission to European Notified Bodies for timely CE marking of new and modified products, with appropriate input from supporting functions (R&D, Quality, Manufacturing, Medical Affairs, etc.). • Represent RA and demonstrate leadership in complex product development teams by identifying and interpreting relevant regulatory requirements and providing actionable regulatory guidance throughout the product development cycle prior to regulatory submission.• Lead regulatory efforts required to comply with new regulations (e.g., EU MDR/IVDR, MDSAP) and other requirements including changes to international standards. • 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. • 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• Assists in developing, maintaining, regulatory strategies, reporting regulatory submission & approval status dashboard & metrics.• Obtains Regulatory Certificates such as CFGs, FSCs• Develop and maintain standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards. • Coordinate and respond to requests for product information, and questionnaires requested by customers. • Identify ways to improve the efficiency of current work process and execute them. • Carry out the above tasks with limited supervision. About you: To be successful in this role, you require:• Minimum bachelor’s degree required in a technical discipline (e.g., engineering, bioengineering, biology, chemistry) preferred.Advanced degree preferred. • Minimum 5 years of Regulatory Affairs experience in medical device or in vitro diagnostic device companies. • Demonstrated ability to resolve problems and to make appropriate regulatory decisions under pressure. • Experience with several international countries RA product registration/assessment (CASAJ, Gr. China, LATAM, Canada, EMEA)• Experience in negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) in medical device and in vitro diagnostic areas.• International product registration experience required. • Proven ability to interpret medical device regulatory requirements, Good Laboratory Practices (GLP), and Quality System Regulations (QSR)• Demonstrated global perspective, customer focus, cross-functional collaboration and teamwork skills. • Current knowledge of European quality system standards, and requirements under the medical device directive MDD 93/42/EEC and knowledge of EU MDR preferred. • Lead, influence and apply feedback from cross functional teams (B2B, Regional and Country RA associates, MDS Business Platforms, and Regulatory bodies).• Digital literacy (SAP, Excel, Pivot Tables, PowerPoint, Access, Agile, Regulatory E-Systems)• Project management experience highly preferred; experience with prioritizing multiple tasks and driving results. • RAC Certification is preferredFor 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.Why Join Us? A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day. 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 health.At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. To learn more about BD visit Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.PDNPrimary Work LocationUSA NJ – Franklin LakesAdditional LocationsWork ShiftBecton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.Apply tot his job