Senior Regulatory Affairs Program Lead (OTTAVA) - MedTech Surgery

6267-Auris Health Inc. Legal Entity; Cincinnati (OH); Hybrid; USD 112,000 - 208,000; Full time

Benefits offered by this job

Vacation 120 hours/yr

Sick time 40 hours/yr

Holiday pay - 13 days/yr

Parental Leave - 480 hours/year

Job summary

Johnson & Johnson is seeking a Senior Regulatory Affairs Program Lead to support the OTTAVA robotics group’s Instrumentation & Accessories portfolio. You will lead regulatory strategy and author regulatory submissions, working with engineering and clinical teams to help achieve US and international approvals.

Preference for candidates near Cincinnati, OH, Santa Clara, CA, or Raritan, NJ, with remote options considered case-by-case.

Qualifications

• Bachelor's degree in science, engineering, or related field required.
• Advanced degree highly desired.

Responsibilities

• Lead regulatory strategy development and execution for robotic instruments and accessories.
• Prepare and submit FDA and global regulatory submissions (Q-submissions, IDEs, De Novo, 510(k)s).
• Collaborate with engineering and clinical teams across product development stages.

Skills

Analytical Reasoning

Business Writing

Coaching

Collaboration

Communication

Regulatory Affairs

Regulatory Submissions

Regulatory Strategy

Education

Bachelor's Degree

Advanced Degree

Job description

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 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 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 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 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 authorities’ 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 Degree required, Advanced Degree highly 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 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 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.

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 and 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 : $112,000.00 - $180,550.00 For Bay Area: $129,000.00 - $208,150.00

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)).

• 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 aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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/. Our Credo calls on us to respect the dignity of every individual and create an environment for all people to thrive. Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities.