Regulatory Affairs Specialist II (Spine) - Orthopaedics

Regulatory Affairs Specialist II

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.

We are searching for the best talent for a Regulatory Affairs Specialist II to support our Spine business. This role must be based within a commutable distance of Raynham, MA. There is no remote option available.

You will be responsible for :

• Providing 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.
• Executing 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.
• Serving as a Regulatory Affairs subject matter expert on new product development and engineering design control teams.
• Guiding conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
• Defining data and information needed for regulatory approvals.
• Developing labeling specifications and approving proposed labeling, packaging, advertising, and promotional materials after evaluating conformance to regulations.
• Providing Regulatory Affairs support during internal and external audits.
• Planning schedules for delivery of supporting documentations required for regulatory submissions on a project and monitoring project through completion.
• Assisting in the development of improved and efficient processes practices for Regulatory Affairs processes.
• Representing Regulatory Affairs on cross-functional project teams, guiding and supporting product development teams on both US and international issues, including Purchased for Resale products.
• Partnering with other functions to define and generate data to assist with regulatory submissions.
• Reviewing and providing regulatory authorization for various changes to product, procedures, etc.
• Responding to requests from foreign governments and / or distributors to prepare and submit documentation for marketing approvals in other countries, as well as providing routine regulatory information to associates and affiliates.

Qualifications / Requirements :

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.

The anticipated base pay range for this position 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 Companys 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.