DePuy Synthes Companies of Johnson & Johnson is recruiting for a Senior Regulatory Affairs Project Lead – Spine , located in Raynham, MA. This is a J&J Flex position with minimum three days of on-site work .
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own. To learn more, visit www.depuysynthes.com .
Key Responsibilities :
· Provides independent regulatory guidance to product development teams in defining regulatory strategies, pre-marketing, and related submissions to support optimal timelines for new/modified product launches in the global market.
· Owns the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but not limited to 510(k) submissions, IDE/IDE Supplements, PMA/PMA Supplements, Annual Reports, HDEs, IND/NDA Supplements, Design Dossiers/Change Notifications, and Technical Files.
· Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
· Defines data and information needed for regulatory approvals.
· Develops labeling specifications and approves proposed labeling, packaging, advertising, and promotional materials after evaluating conformance to regulations.
· Provide Regulatory Affairs support and leadership during internal and external audits.
· Plans schedules for delivery of supporting documentations required for regulatory submissions on a project and monitors project through completion.
· Assists in the development of improved and efficient processes practices for Regulatory Affairs.
· Represents Regulatory Affairs on cross-functional project teams, guiding and supporting product development teams on both US and international issues.
· Partners with other functions to define and generate data to assist with regulatory submissions.
· Review and provide regulatory authorization for Engineering Change Orders (ECOs).
· Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approvals in other countries, as well as provide routine regulatory information to associates and affiliates.
· Direct and coordinate activities concerned with the submission and approval of products to government regulatory agencies.
· Provide guidance to project team members regarding regulatory compliance issues.
· Oversee the preparation and maintenance of regulatory submissions and files of junior associates.
· Establish accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
· Ensure adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.
· Interact with health authorities to expedite approval of pending application and to resolve regulatory matters.
· Consult with management personnel to establish and prepare appropriate regulatory filings for product approvals.
· Work with team members and commercial partners to oversee the regulatory aspects of new products launches, the submission of license applications, and the assessment of the impact product changes have on the status of regulatory licenses.
· Ensure organizational compliance with all applicable regulations and J&J policies.
· Assign projects or activities, provide day-to-day instructions, and suggested training activities to direct reports (if any).
Minimum Qualifications :
· Minimum of a Bachelor’s Degree is required , Advanced degree(s) strongly preferred ; Educational background in scientific, engineering, business, or legal subject areas preferred.
· Minimum 8+ years relevant experience in medical device or other highly regulated industry required; 6+ years with Advanced Degree.
· Knowledge of US and European regulatory processes.
· Must have excellent written, verbal communication and presentation skills.
· Experience in the preparation and submission of US Regulatory files (510(k)s, PMAs) as well as European technical documentations and design dossiers preferred .
· Experience in worldwide regulatory and compliance activities preferred .
· Experience working with cross-functional teams.
· This position will be located in Raynham, MA, and may require up to 10% domestic/international travel.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
This job posting is anticipated to close on 2/15/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.