Associate Director, Regulatory Affairs (Robotics & Digital Solutions) - MedTech Surgery

6267-Auris Health Inc. Legal Entity; Santa Clara (CA); Hybrid; USD 157,000 - 271,000; Full time

Job summary

Johnson & Johnson is seeking an Associate Director, Regulatory Affairs to support our Robotics & Digital Solutions group in Santa Clara, CA. This role will work a Flex/Hybrid schedule with 3 days on-site, and relocation assistance may be provided.

You will lead regulatory strategy for software and vision subsystems across development, submissions, and lifecycle management, ensuring timely market access in the US and globally.

Qualifications

• Bachelor’s degree required; advanced degree preferred.
• 10+ years of regulatory affairs experience in medical devices including software-enabled systems.
• 2+ years of demonstrated people-management experience including direct reports, coaching, and performance management.
• Proven track record of securing regulatory approvals for software enabled devices.
• Strong knowledge of FDA software and cybersecurity regulatory requirements.
• Proven ability to lead complex programs independently.
• Experienced managing multiple projects with complex level of detail.
• Strong verbal and written communications skills.
• Experience with US, EU MDR, and other global markets.
• Experience with vision systems, robotics, and connected medical platforms.

Responsibilities

• 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.

Skills

Regulatory leadership

People management

Cross-functional communication

FDA regulatory knowledge

Software in medical devices

Education

Bachelor's degree

Advanced degree preferred

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 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 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.

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 https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

#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

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through 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 humanity. Learn more at https://www.jnj.com/.

Do Not Sell or Share My Personal Information Limit the Use of My Personal Information