Senior Regulatory Affairs Program Lead (OTTAVA) - MedTech Surgery
Johnson & Johnson · Blue Ash, OH
FULL-TIME
Posted Sep 16, 2026
109K–175K a year
Job Description
## Joining Johnson & Johnson Med. Tech Surgery
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Our Surgery team delivers surgical technologies and solutions to surgeons and healthcare professionals worldwide, helping treat conditions like obesity, cardiovascular disease, and cancer.
We are seeking a **Senior Regulatory Affairs Program Lead** to support our Instrumentation & Accessories team under the OTTAVA robotics group. This role is instrumental in helping OTTAVA reach U.S. and international regulatory approval goals.
### Your Impact
Under minimal supervision, you will lead regulatory strategy development and execution for the robotic instruments and accessories portfolio. You'll work closely with engineering and clinical teams, supporting product development stages, generating submission-ready documentation, and authoring regulatory submissions. You will also support health authority communications.
You will:
- Instill and drive a vibrant regulatory culture as a collaborative teammate across cross-functional groups.
- Apply strategic regulatory thinking and technical expertise to develop and implement strategies for new product clearances and approvals.
- Prepare and submit regulatory information for global market access, including FDA submissions (Q-submissions, IDEs, De Novo, 510(k)s) and international health authority technical documents.
- Serve as the Regulatory Affairs subject matter expert on new product development and engineering design control teams, providing expert feedback on specifications, device testing, risk management, and documentation.
- Proactively identify issues, communicate project timelines, and address complex registration impacts.
- Conduct regulatory evaluation of device changes and generate required submissions (including Letters To File).
- Guide conformance with regulations and guidance documents in product development, claims support, labeling, and promotional materials.
- Assist in developing Regulatory Affairs processes.
### What We’re Looking For
• *Education:**
- Minimum of a Bachelor’s degree required; advanced degree highly desired in Science, Engineering, or related field.
• *Experience:**
- Minimum of 6+ years of related Regulatory Affairs experience within Medical Device required (4+ years with an advanced degree).
- Experience with medical device regulatory new product submissions is required.
- A demonstrated track record of developing and driving regulatory strategies.
- Working knowledge of how global regulations impact product registration.
- Good communication skills for cross-functional collaboration.
- Experience corresponding and collaborating with colleagues globally.
- Ability to evaluate new regulatory requirements and assess business impact.
- Excellent verbal and written communication, strong attention to detail, advanced analytical and problem-solving skills.
- High organizational skills to manage multiple projects simultaneously.
- Strong learning skills for complex technology and presentation skills to communicate complex strategies clearly.
- Up to 25% travel required.
- 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.
### Location & Work Arrangement
Preference will be given to candidates within commutable distance of Cincinnati, OH; Santa Clara, CA; or Raritan, NJ. Remote options will be considered on a case-by-case basis. This role is designated as hybrid.
### Compensation & Benefits
The anticipated base pay range for this position is **$109,000 – $174,800** per year (for Bay Area: $125,000 – $201,250). Subject to plan terms, employees are eligible for:
- Consolidated retirement plan (pension) and savings plan (401(k)).
- Time off benefits including 120 hours vacation, 40 hours sick time (more in CO and WA), 13 paid holidays, up to 40 hours Work/Personal/Family Time, 480 hours parental leave, bereavement leave, caregiver leave, volunteer leave (32 hours), and military spouse time-off.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics.
---
_This job was found on [bandana.com](https://www.bandana.com/?utm_source=jd_attribution&utm_medium=repost)_
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Our Surgery team delivers surgical technologies and solutions to surgeons and healthcare professionals worldwide, helping treat conditions like obesity, cardiovascular disease, and cancer.
We are seeking a **Senior Regulatory Affairs Program Lead** to support our Instrumentation & Accessories team under the OTTAVA robotics group. This role is instrumental in helping OTTAVA reach U.S. and international regulatory approval goals.
### Your Impact
Under minimal supervision, you will lead regulatory strategy development and execution for the robotic instruments and accessories portfolio. You'll work closely with engineering and clinical teams, supporting product development stages, generating submission-ready documentation, and authoring regulatory submissions. You will also support health authority communications.
You will:
- Instill and drive a vibrant regulatory culture as a collaborative teammate across cross-functional groups.
- Apply strategic regulatory thinking and technical expertise to develop and implement strategies for new product clearances and approvals.
- Prepare and submit regulatory information for global market access, including FDA submissions (Q-submissions, IDEs, De Novo, 510(k)s) and international health authority technical documents.
- Serve as the Regulatory Affairs subject matter expert on new product development and engineering design control teams, providing expert feedback on specifications, device testing, risk management, and documentation.
- Proactively identify issues, communicate project timelines, and address complex registration impacts.
- Conduct regulatory evaluation of device changes and generate required submissions (including Letters To File).
- Guide conformance with regulations and guidance documents in product development, claims support, labeling, and promotional materials.
- Assist in developing Regulatory Affairs processes.
### What We’re Looking For
• *Education:**
- Minimum of a Bachelor’s degree required; advanced degree highly desired in Science, Engineering, or related field.
• *Experience:**
- Minimum of 6+ years of related Regulatory Affairs experience within Medical Device required (4+ years with an advanced degree).
- Experience with medical device regulatory new product submissions is required.
- A demonstrated track record of developing and driving regulatory strategies.
- Working knowledge of how global regulations impact product registration.
- Good communication skills for cross-functional collaboration.
- Experience corresponding and collaborating with colleagues globally.
- Ability to evaluate new regulatory requirements and assess business impact.
- Excellent verbal and written communication, strong attention to detail, advanced analytical and problem-solving skills.
- High organizational skills to manage multiple projects simultaneously.
- Strong learning skills for complex technology and presentation skills to communicate complex strategies clearly.
- Up to 25% travel required.
- 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.
### Location & Work Arrangement
Preference will be given to candidates within commutable distance of Cincinnati, OH; Santa Clara, CA; or Raritan, NJ. Remote options will be considered on a case-by-case basis. This role is designated as hybrid.
### Compensation & Benefits
The anticipated base pay range for this position is **$109,000 – $174,800** per year (for Bay Area: $125,000 – $201,250). Subject to plan terms, employees are eligible for:
- Consolidated retirement plan (pension) and savings plan (401(k)).
- Time off benefits including 120 hours vacation, 40 hours sick time (more in CO and WA), 13 paid holidays, up to 40 hours Work/Personal/Family Time, 480 hours parental leave, bereavement leave, caregiver leave, volunteer leave (32 hours), and military spouse time-off.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics.
---
_This job was found on [bandana.com](https://www.bandana.com/?utm_source=jd_attribution&utm_medium=repost)_
Benefits
- Paid time off
- Health insurance
Additional Details
- City
- Blue Ash
- State
- Ohio
- Country
- US
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