BD (Becton, Dickinson and Company) Manager, MDR & Regulated Substances in Franklin Lakes, New Jersey
Job Description SummaryReporting to the Director of Global Product Stewardship, this position will set strategy and coordinate the Medical Device Regulation and Regulated Substances program to ensure that all BD Business units have the programs, processes and systems in place to meet substance reporting and labelling obligations. This role will focus primarily on the EU Medical Device/In Vitro Diagnostics Regulations and but will support other Regulated Substance r requirements, such as California Proposition 65, as needed.
The Manager, MDR & Regulated Substances will evolve BD’s Regulated Substance programs with changing external drivers, including regulatory, customer and other stakeholder requirements. They will ensure strategy development and alignment with individual business unit MDR resourcing and product prioritization plants. The Manager will translate strategy into implementation plans, develop processes, and define systems to govern regulated substances in BD products.
Responsible for setting overall strategy to establish the substance data review process in support of the EU MDR/IVDR. Serve as the primary liaison on Regulated Substance compliance activities with the MDR Program Office, Business Units, Procurement and Product Stewardship teams.
Establish cross business program team to develop process, work instructions, systems and guidance with clear responsibilities and timing - aligned with Business Units - to complete the implementation of new MDR substance reporting and labelling requirements and creation of EU MDR/IVDR Technical files.
Identify any gaps that exist and, working with appropriate business, regional, and/or functional groups, make recommendations to MDR program office for filling those gaps as needed.
Establish a quality system for Product Stewardship to manage CMRs and Endocrine Disruptor substance information to meet all quality standards applicable to the creation of Regulatory information such as Technical files.
Closely collaborates with Supply Base Compliance and Business unit’s teams on data collection, materials in scope, prioritization and reported substances.
Supports Business Unit and Corporate Preclinical Development team to assess potential removal of hazardous substances or develop harmonized justification declarations for those substances that cannot be removed.
Work with labeling team to prepare for Product hazardous substance labeling, and advise on labeling standards including MDR, GHS, Cal Prop 65 in conjunction Medtech and other industry working groups and BD Regulatory and Quality teams.
Monitor new or changing substance classifications that require product and data review to assess need to update technical file and labeling if needed.
Support process to track product changes/new product to assess regulated Substances, including MDR substances in early product design or Sustaining engineering.
Establish centralized dataset(s) for BD products to feed EU Eudamed and other regulated substance databases or reporting requirements.
Interface with and represent BD in EU Medtech MDR Working Groups, as needed.
BS or MS in chemistry, engineering, environmental health science, regulatory affairs or related technical discipline
Minimum experience of 4-7 years of experience in an FDA regulated industry and at least three years in Product Stewardship, Quality, Regulatory, Chemical engineering or R&D including development of policies, regulated process and systems.
Knowledge of environmental legislations, regulatory assessment and interpretation, especially specific to product stewardship requirements around reportable substances
Strong project management and facilitation skills required to work with cross-functional business teams in Quality, Regulatory, Engineering and Research & Development without direct authority.
Excellent verbal and written communication skills including the ability to make clear and concise presentations.
Strong management, problem solving and decision-making skills.
Systems savvy and experience organizing data from various systems. Knowledge of SAP or other ERP systems preferred.
Sphere of influence:
The sphere of influence is global, working with all BD business units to meet the regulated substance requirements for EU MDR and other regulated substance legislations.
Primary Work LocationUSA NJ - Franklin Lakes
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