The Staff Regulatory Affairs Specialist will be working in BD Medical Pharmaceutical Systems – Advanced Drug Delivery Solutions (BDM-PS ADDS), primarily the Wearable Injection Platform. In BDM-PS ADDS we develop novel and complex drug delivery solutions to allow patients to self-administer their medication.
This position will lead regulatory programs to support new product development for connected drug delivery solutions, which may include software as a medical device (SaMD), mobile medical apps and/or embedded software (SiMD) as part of electro-mechanical devices. You will work on a collaborative team across multiple functions to integrate a successful regulatory strategy for products and services aligned with connected drug delivery solutions; developing and maintaining effective and mutually positive relationships across BD businesses, functions, partner companies, and with the FDA. You will provide regulatory expertise to identify, prevent, and solve complex regulatory issues for new product development. Your ability to influence early development, apply lessons learned, from other product development and competitor knowledge is crucial.
Recommend and execute high quality and timely regulatory strategies to ensure well-informed decisions are made on new product development or lifecycle planning.
Collaborate with cross-functional team and key stakeholders (global regulatory, commercial, product safety, R&D, legal, quality, medical affairs etc.) to ensure regulatory contributions achieve the objectives in the strategy, achieve agreed standards, to maximize overall project delivery time and customer deliverables.
Participate in interactions with regulatory authorities to seek guidance on new product development or expedite review of BD products in support of pending customer applications.
Provide guidance to junior RA associate team members to have strong regulatory capabilities.
Support customer discussions and combination product development activities.
Proactively identify potential regulatory risks and recommend solutions within defined scope of responsibility on the business.
Support the development of the strongest claims/advertising and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
Review labeling, product materials and technologies for acceptability.
Maintain high level of knowledge on the science of products within defined portfolio and emerging areas of self-care technologies.
Accountable for ongoing end-to-end regulatory compliance of products in assigned portfolio
Understand the industry trends and regulatory challenges with the digital health space via external partnerships and participation in advocacy groups and an understanding of market trends and competitive activities.
Strategic Skills: Understanding the regulatory landscape and business needs
Understands the regulatory landscape on a global level for product portfolio, understands the current business working in a B2B model and anticipates the customer needs, able to articulate changes in the regulatory landscape and how they relate to the business, product portfolio and customer, and create regulatory position on changes to the landscape and influence requirements, whenever possible
Organizational Positioning Skills: Comfort Around Senior Management and Influence Core Team
Can deal comfortably with and influence senior management; can present without undue tension and nervousness; understands how to work effectively with and influence multiple functions; can recommend approaches likely to be seen as appropriate and positive.
Personal and Interpersonal Skills: Collaboration
Can negotiate skillfully in tough situations with new product development Core Team; can settle differences with minimum noise; can win concessions without damaging relationships; can be direct and diplomatic; quickly gains trust of others.
Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline.
8 years working in Regulatory Affairs experience, with increasing levels of responsibility.
Additional and Preferred Qualifications
Professional certification(s) preferred
Experience working with software (including IEC 62304), electro-mechanical medical devices (including IEC 60601-1) and wireless medical devices preferred
Demonstrated technical regulatory work on device filing (IDE, 510(k), PMA, De Novo) and combination product filing (IND, BLA, NDA) preferred
Strong understanding of global device and combination product regulations (US, EU, Canada, ROW)
Experience engaging with FDA’s Digital Health Program a plus
Strong technical knowledge of medical products, software experience preferred
Strong technical understanding of relevant procedures, practices, and associated medical terminology
Thorough knowledge of product development process and design control is a must
Ability to manage multiple projects with research and analytical skills
Excellent written and oral communication, technical writing and editing skills
Strong leadership, interpersonal and influencing skills
Proficiency with Microsoft Office
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.
Internal Number: R-376461
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