Senior Regulatory Affairs Program Lead (OTTAVA) - MedTech Surgery

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:

Professional

All Job Posting Locations:

Remote (US), 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 a  Senior Regulatory Affairs Program Lead  to support our OTTAVA robotics group. Preference will be given to candidates located within a commutable distance of Santa Clara, CA however remote options will be considered on a case-by-case basis and if approved by the company.

Purpose : In joining our growing regulatory team, the Sr. Regulatory Affairs Program Lead will help OTTAVA reach US and international regulatory (NPD) approval goals. Under minimal supervision, the selected candidate will lead regulatory strategy development and execution for the robotic systems 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 :

• ·         Prepare and execute regulatory strategies for NPD and LCM projects.
• ·         Serve as strategic regulatory lead across product development, submission, approval, and LCM activities.
• ·         Serves as a regulatory SME on cross-functional partners with strong knowledge of electromechanical devices with software enabled functionality. Responsibilities include conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, labeling and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission.
• ·         Prepare and submits regulatory information required to obtain timely US market access, including preparation, writing and filing of FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s). Lead FDA meeting preparation.
• ·         Executes sustaining activities including change assessments, Letter To File, registrations and renewals.
• ·         Support global health authorities’ submissions technical documents.
• ·         Applies expert knowledge of guidances, regulations, and standards relevant to product portfolio.
• ·         Support audits.

Qualifications / Requirements :

• ·         Minimum of a Bachelor’s degree required ; Advanced Degree strongly preferred .
• ·         At least 6+ years of regulatory affairs experience in medical devices including experience with software-enabled systems .
• ·         Proven track record of securing regulatory approvals (e.g., 510ks, IDEs, De Novos)
• ·         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 (guidances, regulations, trends., etc.) to provide regulatory strategy that drives towards business priorities/needs.
• ·         Advanced problem-solving skills.
• ·         Experienced in evaluating new regulatory requirements as well as regulatory changes for projects impact.
• ·         Experienced leading multiple projects with complex level of detail.
• ·         Experience supporting US market.
• ·         This position may require up to 10% travel.

Preferred Qualifications

• ·         Previous experience health authority meetings and preparation for meetings
• ·         Experience with vision systems, robotics, and connected medical platforms.
• ·         Experience with IEC 60601 series and ISO 10993-1.
• ·         Strong knowledge of FDA software and cybersecurity regulatory requirements.
• 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.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking

The anticipated base pay range for this position is :

$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 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