Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
Cincinnati, Ohio, United States of America, Santa Clara, California, United States of America
Job Description:About Surgery
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for aSenior Regulatory Affairs Program Leadto support our Instrumentation & Accessories 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. 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 lead regulatory strategy development and execution for the robotic instruments and accessories portfolio. They will work closely with exceptional engineering and clinical teams, supporting product development stages, generating submission ready documentation, and authoring regulatory submissions. Additionally, this individual will support health authority communications.
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 authorities9 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 Bachelor's 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 is required (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 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.
#LI-Hybrid
Required Skills:
Preferred Skills:
The anticipated base pay range for this position is :
$109,000.00 - $174,800.00
For Bay Area:
$125,000.00 - $201,250.00
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees are eligible to participate in the Company9s 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 Colorado 148 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 180 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave 80 hours in a 52-week rolling period10 days
Volunteer Leave 32 hours per calendar year
Military Spouse Time-Off 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
