Regulatory Affairs Manager – RA Strategy Lead (hybrid)

Job Description Summary Job Description We 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.Job Overview Working closely with the Director of Regulatory Affairs, the Regulatory Affairs Manager — RA Strategy Lead will provide proactive regulatory surveillance. They will develop regulatory strategies for product creation and market entry. They will also serve as the regulatory advisor on innovation teams. This role is critical for proactively identifying regulatory changes and effectively communicating them to the business, ensuring swift understanding and compliance planning. This position will support the innovation council by providing upfront regulatory assessments to help guide planning through timely concept and product development. The role will engage in policy shaping to allow the business to navigate the regulatory landscape effectively.Responsibilities Proactively monitor global regulatory developments to identify potential impacts on product portfolio. Deliver timely and actionable insights to stakeholders, ensuring alignment with business strategy.Collaborate with cross-functional teams to develop plans addressing evolving regulations and standards that support product innovation and entry into markets.Serve as a regulatory advisor to innovation teams, providing mentorship on compliance and guidelines throughout the product lifecycle. Facilitate knowledge sharing to integrate regulatory considerations early in the development process.Assess potential regulatory risks associated with product development and market strategies. Propose and implement mitigation strategies to safeguard our innovation efforts.Responsible for effectively communicating trends in regulatory changes early to the organization. Ensure that all teams are informed and prepared to adapt to upcoming changes, fostering a proactive compliance culture.Champion a culture of regulatory excellence by providing training and support to internal teams. Foster awareness and understanding of regulatory obligations across the organization.Education Bachelor’s degree required in Life Sciences, Engineering, or a related fieldExperience Minimum of 5 years of experience in regulatory affairs within the medical device industryKnowledge and Skills Comprehensive understanding of medical device regulations, standards, and the regulatory submission landscape (e.g. FDA, EU MDR, EU IVDR, ISO)Proven experience in developing and implementing regulatory strategies.Exceptional analytical and strategic thinking abilities.Strong communication and interpersonal skills, with a proven ability to influence stakeholders.Effective project management skills and attention to detail.Proactive, adaptable, and results-driven, with a passion for regulatory excellence and innovation.Ability to work collaboratively in a cross functional team environment.Knowledge of quality management systems and risk management principles.At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under “Our Commitment to You”.Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.Salary Range Information:$132,400.00 – 218,400.00 USD AnnuallyAt 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 BonusPotential Discretionary LTI BonusHealth and Well-being BenefitsMedical coverageHealth Savings AccountsFlexible Spending AccountsDental coverageVision coverageHospital Care InsuranceCritical Illness InsuranceAccidental Injury InsuranceLife and AD&D insuranceShort-term disability coverageLong-term disability insuranceLong-term care with life insuranceOther Well-being ResourcesAnxiety management programWellness incentivesSleep improvement programDiabetes management programVirtual physical therapyEmotional/mental health support programsWeight management programsGastrointestinal health programSubstance use management programMusculoskeletal surgery, cancer treatment, and bariatric surgery benefitRetirement and Financial Well-beingBD 401(k) PlanBD Deferred Compensation and Restoration Plan529 College Savings PlanFinancial counselingBaxter Credit Union (BCU)Daily PayCollege financial aid and application guidanceLife Balance ProgramsPaid time off (PTO), including all required State leavesEducational assistance/tuition reimbursementMetLife Legal PlanGroup auto and home insurancePet insuranceCommuter benefitsDiscounts on products and servicesAcademic Achievement ScholarshipService Recognition AwardsEmployer matching donationWorkplace accommodationsOther Life Balance ProgramsAdoption assistanceBackup day care and eldercareSupport for neurodivergent adults, children, and caregiversCaregiving assistance for elderly and special needs individualsEmployee Assistance Program (EAP)Paid Parental LeaveSupport for fertility, birthing, postpartum, and age-related hormonal changesLeave ProgramsBereavement leavesMilitary leavePersonal leaveFamily and Medical Leave (FML)Jury and Witness Duty LeaveWhy 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 visitBecton, 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 .Primary Work Location USA NJ – Franklin LakesAdditional LocationsWork Shift NA (United States of America)At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under .Salary or hourly rate ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.Salary Range Information $132,400.00 – $218,400.00 USD Annual

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