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Senior Staff Regulatory Affairs Specialist

Company: BD
Location: Franklin Lakes
Posted on: November 23, 2020

Job Description:

Job Description SummaryBD is a global medical technology company focused on addressing many of the world's most pressing and evolving health needs\. We are transforming the quality and cost of care for patients and clinicians worldwide and are dedicated to advancing the world of health by staying at the forefront of the medical technology development\. You will be working in a fast\-pace, stimulating environment with great people\.BD offers a very competitive compensation and a generous benefits package, strong leadership commitment to individual empowerment and learning, and on\-site health and fitness centers at our Franklin Lakes location\. BD---s headquarters are located in scenic Franklin Lakes, NJ, close to major metropolitan routes that provide easy access to numerous academic, arts, leisure, sports and historic areas of interest\.Join us in our mission to advance the world of health\. Job DescriptionThe 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\.Growth 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 \(global regulatory, commercial, product safety, R, legal, quality, medical affairs etc\.\) 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\.Simplify 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\.Empower 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\.Critical CompetenciesStrategic 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 possibleOrganizational 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\.Requirements 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 OfficeBecton, 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\.\LI\-PRO\LI\-TECH Primary Work LocationUSA NJ \- Franklin Lakes Additional Locations Work ShiftUS BD 830am\-5pm FLakes Core Hours \(United States of America\)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.

Keywords: BD, New York , Senior Staff Regulatory Affairs Specialist, Other , Franklin Lakes, New York

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