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Reporting to Medication Management Systems (MMS) Pharmacy Automation (PA) Manager of Regulatory Affairs, the Specialist of Regulatory Affairs provides regulatory expertise to MMS-PA platform. This individual facilitates the regulatory affairs activities within the MMS-PA platform. The individual contributes to the development of MMS-RA strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programs. Such assessments may influence the scientific or technical direction of product design and/or development in support of worldwide registrations. The Specialist of Regulatory Affairs will ensure functional excellence in regulatory activities to achieve timely worldwide clearance, approval, registration, and licensure of MMS-PA products with desired claims. This individual will help communicate new developments in worldwide regulations affecting MMS-PA products to MMS-PA collaborators.
Job Responsibilities:
Reporting to Medication Management Systems (MMS) Pharmacy Automation (PA) Manager of Regulatory Affairs (MMS-PA) the Specialist of Regulatory Affairs (RA) provides pre-market regulatory expertise to MMS-PA business.
Facilitates the premarket regulatory affairs activities within MMS-PA.
Contributes to the development of MMS-PA strategic and operational plans through sound assessments of regulatory pathways and risks, and sound regulatory programs
Ensures functional excellence in regulatory activities to achieve timely worldwide clearance, approval, registration, and licensure of MMS-PA products with desired claims
Communicates new developments in worldwide regulations affecting MMS-PA products to MMS-PA collaborators
Coordinates and advises the preparation of regulatory submissions, including EU Technical Files for CE mark (Machinery Directive), and materials required for global registration of products
Provides a high degree of regulatory expertise and experience to MMS-PA’s new product development programs, serving as a Core Team advisor and champion for MMS-PA’s Global Product Development System (GPDS)
Serves as a regulatory expert for labeling and promotional materials review, experimental designs, and data analysis as they relate to registration and commercialization of PA products
Reviews product development protocols to assure collection of appropriate data for product release, regulatory submissions and regulatory compliance
Coordinates with Quality function on compliance activities and responses to quality audit findings
Effectively deploys appropriate management ‘standard processes’ to ensure a team of dedicated, engaged and efficient RA associates
Drives improvements in capability, such as customer centricity, regulatory knowledge, effective team participation and communication
Instills a culture of continuous improvement by identifying and implementing improvements to support and achieve functional excellence
Participates when needed in activities associated with Field Corrective Action (FCA) reviews by the FAC committee, and supports regulatory and notified body inspections. This includes routine interaction with Quality and Regulatory Compliance personnel.
Qualifications:
Experienced knowledge in US and global electrical equipment regulations.
Demonstrated ability to perform critical thinking at a high level of proficiency, to exercise independent judgement and discretion within a broadly defined range of policies and practices.
Demonstrated ability to deliver desired outcomes via innovative ideas and approaches.
Demonstrated discernment and critical thinking skills.
Excellent communication (oral/written) and negotiation skills.
Demonstrated prioritization, organizational and planning skills, including committed, focused vitality and working towards results to meet business strategies and needs. Orientation for detail work product, with emphasis on accuracy and completeness.
Validated problem solving skills: identifies potential problems, including situations that include ambiguity, by actively reviewing and analyzing internal and external factors. Assesses potential impact and/or applicability to other related areas. Assesses corrective action to assure it prevents recurrence. Able to confidently deal with ambiguous issues and/or rapid changes, and provide input towards suitable actions.
Excellent interpersonal skills. Effective at working with teams working across functions, across regions, and within a matrix organization.
Is a change agent.
Experienced with continuous improvement projects, project management, product development processes, and design control.
Education and Experience:
B.A. or B.S. degree in health science or life science field (biology, microbiology, chemistry, engineering, medical technology, etc.)
MS degree in health science, regulatory affairs, or applicable subject area a plus
RAC Certification a plus
Minimum of 5 years directly applicable regulatory affairs work experience (e.g., IVD 510(k), PMA, de novo, IVDD and IVDR compliant tech files, etc.) in a medical device company.
Experienced with continuous improvement projects, project management, product development processes, and design control.
Experienced knowledge in US and global regulations required, electrical equipment regulations experience/knowledge strongly preferred
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.
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 https://bd.com/careers
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.
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Primary Work LocationUSA NC - Durham - Roche DriveAdditional LocationsWork Shift