At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Regulatory Affairs Group **Job Sub** **Function:** Regulatory Affairs **Job Category:** Professional **All Job Posting Locations:** Raynham, Massachusetts, United States of America **Job Description:** We are searching for the best talent for a **Regulatory Affairs Specialist II** to support our Spine group. _This role will be based in our Raynham, MA office and will work a Flex/Hybrid schedule with 3 days per week in office_ . There is NO remote option. **You will be responsible for** : + Provides 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. + Execute on the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers, including, but not limited to 510(k) submissions, Pre-Submissions, HDEs, Change Notifications, Technical Documents, and correspondence with Notified Bodies. + Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams. This includes conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission. + 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 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 processes. + Represents Regulatory Affairs on cross-functional project teams, guiding and supporting product development teams on both US and international issues, including Purchased for Resale products. + 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. **Qualifications / Requirements** : + Minimum of a Bachelor’s Degree **required** , Advanced Degree _strongly preferred_ . Desired fields of study include science, engineering (e.g., biomedical, electrical, software, mechanical), business, legal, or similar. + **Minimum 2+ years of professional regulatory experience** in a highly regulated industry, preferably in medical device or pharmaceutical ( _1+ years with Advanced Degree_ ). + Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are **required** . + Experience in the preparation and submission of US regulatory filings (e.g., 510(k), PMA) as well as European technical documentation reports files is _strongly preferred_ . + Knowledge of US and European regulatory processes is _preferred_ . + Must have excellent written, verbal communication, collaborative and strong attention to detail skills. + High organizational skills with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks. + Strong learning skills for complex technology and presentation skills to allow presentation of complex regulatory strategies in a clear, concise, and comprehensive fashion. + Up to 10% travel may be required. Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource. \#LI-Hybrid **The anticipated base pay range for this position is :** The base pay range is $74,000 to $119,600. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits