Regulatory affairs associate Jobs in Brockton, MA

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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 : About Orthopaedics

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopaedics Ready to join a team thats reimagining how we heal Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports extremities and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at & Johnson announced plans to separate our Orthopaedics business toestablish a standalone orthopaedics company operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months subject to legal requirements including consultation with works councils and other employee representative bodies as may be required regulatory approvals and other customary conditions and approvals.

Should you accept this position it is anticipated that following conclusion of the transaction you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes programs policies and benefit that case details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

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 :

• 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 various changes to product procedures etc.
• 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 :

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 or contact AskGS to be directed to your accommodation resource.

#LI-Hybrid

Required Skills : Preferred Skills :

The anticipated base pay range for this position is :

The base pay range for this position is $74000 to $119600.

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. Experience :

IC

Key Skills

Athletics,Corporate Banking,Dreamweaver,Facilities,IT Support

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 74000 - 119600