Job Function: Regulatory Affairs Group
Job Sub Function: Regulatory Affairs
Job Category:People Leader
All Job Posting Locations: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 an
Associate Director, Regulatory Affairs to support our Robotics & Digital Solutions group. This role will work a Flex/Hybrid schedule with 3 days per week on-site and must be located in Santa Clara, CA. Relocation assistance may be provided on a case-by-case basis and if approved by the company.
You will be responsible for:
- Serve as regulatory leader for software and vision subsystems across product development, submission, approval, and LCM activities.
- Define and execute regulatory strategies for software subsystem, vision systems, endoscopes, and integrated robotic system; including NPD and LCM stages.
- Obtain timely market access for new product introduction and enable lifecycle management activities in the US and support OUS activities.
- Manage premarket regulatory submissions to US FDA including 510(k)s, IDE, Q-Subs, etc. as well as sustaining activities including change assessments, Letter To File, registrations and renewals. Support and enable global registrations.
- Manage software and vision regulatory team- Lead and develop regulatory team members, serving as a coach and mentor.
- Manage internal resources or contractor SMEs to deliver submissions or other project objectives.
- Serve as regulatory subject matter expert to cross-functional partners with strong knowledge of software lifecycle, cybersecurity, and connected systems.
- Applies expert knowledge of guidance's, regulations, and standards relevant to product portfolio.
- Supports audits.
Qualifications / Requirements:
- Minimum of a Bachelor's degree is required; Advanced Degree strongly preferred.
- At least 10+ years of regulatory affairs experience in medical devices including experience with software-enabled systems.
- 2+ years of demonstrated people-management experience including direct reports, coaching, and performance management required.
- Proven track record of securing regulatory approvals for software enabled devices required.
- Strong knowledge of FDA software and cybersecurity regulatory requirements required.
- Proven ability to lead complex programs independently.
- Proven ability to be highly collaborative & flexible - comfortable navigating through ambiguity.
- Excellent cross-functional communicator; able to influence within the regulatory team and across functions.
- Independent strategic thinker, able to synthesize regulatory pertinent information (guidance's, regulations, trends., etc.) to provide regulatory strategy that drives towards business priorities/needs & demonstrates view of bigger picture.
- Experienced managing multiple projects with complex level of detail.
- Strong verbal and written communications skills
- Experience supporting US, EU MDR, and other global markets.
- Experience with vision systems, robotics, and connected medical platforms strongly preferred.
- Experience with IEC 60601 series and ISO 10993-1 strongly preferred.
#LI-Hybrid
Required Skills:Preferred Skills:Business Writing, Compliance Risk, Developing Others, Fact-Based Decision Making, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Legal Support, Managing Managers, Operations Management, Policy Development, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Strategic Thinking
The anticipated base pay range for this position is :$157,000.00 - $271,400.00
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
