Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery, Inc.
Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery, Inc.
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$ 121000 - 194350
1 Vacancy
Job Description
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 GroupJob Sub Function:
Regulatory AffairsJob Category:
ProfessionalAll Job Posting Locations:
Cincinnati Ohio United States of America Santa Clara California United States of AmericaJob Description:
We are searching for the best talent for a Senior Regulatory Affairs Program Lead to support our Robotics & Digital Surgery team. The preferred location for this role is Cincinnati OH however Santa Clara CA is also available as a location. This role will work a Flex/Hybrid schedule with 3 days per week in-office. There is NO remote option. Relocation assistance may be available on a case-by-case basis.
Purpose: In joining our growing regulatory team the Sr. Regulatory Affairs Program Lead will help Robotics & Digital Solutions reach US and international regulatory (NPD) approval goals. Under minimal supervision the selected candidate will be working on the robotics instruments and accessories portfolio RA needs working closely with exceptional engineering and clinical teams as well as supporting product development stages and generating submission ready documentation and authoring regulatory submissions. Additionally this individual will support health authority communications and participate in strategy development.
You Will Be Responsible For:
- Instills and drives a vibrant regulatory culture working among cross functional groups as a teammate and collaborator.
- Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals.
- Prepares and submits regulatory information required to obtain global market access including preparation writing and filing of FDA submissions (e.g. Q-submissions IDEs De Novo 510(k)s) and global health authorities submissions technical documents.
- 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.
- Proactively identify issues effectively communicate timelines for project completion and address complex issues that may impact registration status.
- Conduct regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission (including Letters To File)
- Guides conformance with applicable regulations and guidance documents in product development support of claims content labeling and promotional materials.
- Assists in the development of Regulatory Affairs processes.
Qualifications / Requirements:
- Minimum of a Bachelors Degreerequired Advanced Degreehighly desired; desired areas of study include Science Engineering or related field.
- Minimum of 6 years of related Regulatory Affairs experience within Medical Device isrequired(4 years with Advanced Degree).
- Experience with medical device regulatory new product submissionsrequired.
- A demonstrated track record of developing and driving implementation of regulatory strategies.
- Working knowledge of how global regulations impact product registration.
- Good communication skills for effective collaboration with cross-functional partners.
- Corresponding and collaborating with J&J colleagues globally for strategic contribution and achievement of regulatory milestones.
- Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.
- Excellent verbal and written communication skills; strong attention to detail.
- Advanced analytical and problem-solving skills.
- High organization 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.
- This position will require up to 25% travel.
- Previous experience with health authority meetings/interactions
- Experience with medical device software guidance IEC 60601 sterilization biocompatibility and reprocessing requirements and their documentation in submissions.
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 and 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 email the Employee Health Support Center () or contact AskGS to be directed to your accommodation resource.
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The anticipated base pay range for this position is :
The anticipated base pay range for Cincinnati OH is $105000 to $169050; for the Bay Area the base pay range is $121000 to $194350.Additional Description for Pay Transparency:
The Company maintains highly competitive performance-based compensation programs. Under current guidelines this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis. Employees and/or eligible dependents may be 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. Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation up to 120 hours per calendar year Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington up to 56 hours per calendar year Holiday pay including Floating Holidays up to 13 days per calendar year of Work Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. Experience:Senior IC
Employment Type
Full-Time
Key Skills
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