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Senior Regulatory Affairs Specialist
Requisition ID: 7019180323
LifeScan, Inc., a member of Johnson & Johnson Family of
Companies, is recruiting for a Senior Regulatory Affairs Specialist
based in Chesterbrook, PA.
As the market leader and maker of blood glucose monitoring systems, LifeScan, Inc., a Johnson & Johnson Company, is dedicated to improving the quality of life for people with diabetes through our OneTouch® Brand of blood glucose monitoring systems. The ONETOUCH® Brand of consumer products includes portable electronic meters and disposable reagent test strips to provide accurate glucose readings, and also the software tools to transform this information into actionable health care decisions. To find out more about LifeScan, please visit our website at www.LifeScan.com.
The Senior Regulatory Affairs Specialist will be working within a cross-functional product development team. The role will provide regulatory leadership for design, development and sustaining activities for existing and new Digital Diabetes Management Tools which interface with blood glucose monitoring systems.
- Collate global regulatory requirements to develop effective Digital regulatory strategies for delivering optimal timelines for new/modified product approvals.
- Provide independent regulatory guidance to business partners and cross functional project teams, communicate Digital regulatory environment and product submission requirements
- Prepare pre-market applications to US and EU regulatory agencies.
- Partner with global regulatory affiliates to facilitate the preparation and submission of in-country registration dossiers for new and existing products, by understanding local regulatory requirements, and sourcing and providing required documentation to meet timelines.
- Guide conformance with applicable regulations in product development, support of claims, labeling content, and promotional materials
- Develop labeling specifications and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations
- Provide Regulatory Affairs support during internal and external audits
- Plans schedules for regulatory deliverables on a project and oversees project through completion
- Assists in the development of best practices for Regulatory Affairs processes
- Represents Regulatory Affairs on cross-functional project teams as required
- Partners with other functions to define and obtain data to assist with regulatory submissions
- A minimum of a Bachelor’s Degree is required. An advanced degree (Masters, PhD, PharmD, etc.) is preferred.
- A minimum of 4 years direct experience in Regulatory Affairs is required.
- Regulatory Affairs experience within the medical device industry with knowledge of IVD or MD regulations in US and/or EU.
- Specific knowledge of regulatory requirements for Software as accessory to MD/IVD and as Standalone MD.
- Demonstrated experience in new product development; and compiling and submitting EU (CE File) and/or US (510(k)) pre-market submissions.
- This position is based in Chesterbrook, PA and will require a minimum of 5% travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
Lifescan Inc. (6097)