Summary of duties: Assessing necessity for reporting changes to FDA/Notified Body for proposed device modifications. Preparing robust reporting justifications for changes that do not require supplements or notices. Sending notifications of change to EU Notified Body as required. Collaborating with international regulatory associates to assess necessity for reporting changes to global regulatory authorities for device modifications. Identifying and communicating appropriately quantified risks and mitigation strategies associated with regulatory strategies to stakeholders. Providing cross-functional support for regulatory submissions and compliance including review and approval of product labeling, promotional, and advertising materials to ensure regulatory compliance. Writing and updating standard operating procedures, work instructions, and policies to maintain compliance with applicable regulations and standards. Maintaining regulatory databases/systems for key regulatory data. Identifying and communicating appropriately quantified risks and mitigations associated with global regulatory strategies to cross-functional collaborators. Providing regulatory support during internal/external audits and inspections. Qualifications: Master’s degree in Health Science, Life Science, Regulatory Affairs (any), Biology, Chemistry, Engineering (any) or related field of study and two (2) years of experience in the job offered or related occupation in which the required experience was gained. In lieu of a Master’s degree in Biology, Chemistry, Engineering (any) or related field of study and two (2) years of experience, the employer will also accept a Bachelor’s degree in Health Science, Life Science, Regulatory Affairs (any), Biology, Chemistry, Engineering (any) or related field of study and five (5) years of work experience in the job offered or related occupation in which the required experience was gained. Applicants must also have demonstrated experience in the following: Negotiating with regulatory authority personnel (e.g. FDA, Notified Bodies) in medical devices; International product registration experience; US medical device regulations, 21 CFR 820 -Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards and Good Laboratory Practice regulations; Hazardous materials management; 510(k), - Quality System Regulation, and working knowledge of standards and FDA guidances; and All material related regulatory requirements (Prop 65, CONEG, DOT, IATA, IMO, and OSHA) in the US, Europe and Canada.Position is a 100% telecommuting role. Reports to company headquarters in Franklin Lakes, NJ. Can work remotely or telecommute. To apply, mail resume to: Becton, Dickinson and Company, Attn: BDHR - CS, 3750 Torrey View Ct., San Diego, CA 92130, or submit a resume to https://nj.gov/labor/career-services/, or submit a resume to https://bdx.wd1.myworkdayjobs.com/EXTERNALCAREERSITE_USA. Must reference Job Title: Senior Regulatory Affairs Specialist. Code: R-502018. EOE.