Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category:Professional
All Job Posting Locations:Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America, Remote (US), Santa Clara, California, United States of America
Job Description:About SurgeryFueled 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 a
Senior Regulatory Affairs Specialist to support our Instrumentation & Accessories team under the OTTAVA robotics group. Preference will be given to candidates located within a commutable distance of Cincinnati, OH, Santa Clara, CA, or Raritan, NJ however remote options will be considered on a case-by-case basis.
Purpose: In joining our growing regulatory team, the Sr. Regulatory Affairs Specialist 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:
- Applies strategic regulatory thinking along with technical expertise to 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 including 510(k)s and global health authorities' submissions technical documents.
- Proactively identifies issues, effectively communicates timelines for project completion, and addresses issues that may impact registration status.
- 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 Degree required, Advanced Degree highly desired; desired areas of study include Science, Engineering, or related field.
- Minimum of 4+ years of related Regulatory Affairs experience within Medical Device is required (3+ years with Advanced Degree).
- Experience with medical device regulatory new product submissions required.
- 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.
- 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 preferred.
- Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and their documentation in submissions preferred.
#LI-Hybrid
Required Skills:Preferred Skills:Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork
The anticipated base pay range for this position is :$92,000.00 - $148,350.00
For Bay Area:
$106,000.00 - $170,200.00
Additional Description for Pay Transparency:
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 Colorado -48 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
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
