Johnson & Johnson
Senior Regulatory Affairs Specialist (Robotics & Digital Solutions) - MedTech Su
Johnson & Johnson, Cincinnati, Ohio, United States, 45208
Robotics & Digital Solutions, part of the Johnson & Johnson Medtech Surgery, is recruiting for a Senior Regulatory Affairs Specialist. The preferred location for this role is within a commutable distance of Cincinnati, OH; however, candidates within commutable distance of Santa Clara, CA or Raritan, NJ will also be considered. This role will work a Flex/Hybrid schedule with 3 days per week on-site.
About Johnson & Johnson
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/ .
In joining our growing regulatory team, the Sr. Regulatory Affairs Specialist will help Robotics & Digital Solutions reach US and international regulatory (NPD) approval goals. Under minimal supervision, the selected candidate will be working on the robotics, instruments, and accessories portfolio RA needs, working closely with exceptional engineering and clinical teams, as well as supporting product development stages and generating submission-ready documentation and authoring regulatory submissions. Additionally, this individual will support health authority communications and participate in strategy development.
Key Responsibilities:
Applies strategic regulatory thinking along with technical expertise to 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 including 510(k)s and global health authorities’ submissions technical documents.
Proactively identifies issues, effectively communicates timelines for project completion, and addresses issues that may impact registration status.
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.
The anticipated base pay range for this position is $88,000 to $141,450. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
https://www.careers.jnj.com/employee-benefits
QualificationsRequired Qualifications:
Minimum of a Bachelor's Degree required, Advanced Degree highly desired; desired areas of study include Science, Engineering, or related field.
Minimum of 4+ years of related Regulatory Affairs experience within Medical Device is required (3+ 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 J&J 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.
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.
Preferred Qualifications:
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 Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
www.careers.jnj.com .
#J-18808-Ljbffr
About Johnson & Johnson
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/ .
In joining our growing regulatory team, the Sr. Regulatory Affairs Specialist will help Robotics & Digital Solutions reach US and international regulatory (NPD) approval goals. Under minimal supervision, the selected candidate will be working on the robotics, instruments, and accessories portfolio RA needs, working closely with exceptional engineering and clinical teams, as well as supporting product development stages and generating submission-ready documentation and authoring regulatory submissions. Additionally, this individual will support health authority communications and participate in strategy development.
Key Responsibilities:
Applies strategic regulatory thinking along with technical expertise to 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 including 510(k)s and global health authorities’ submissions technical documents.
Proactively identifies issues, effectively communicates timelines for project completion, and addresses issues that may impact registration status.
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.
The anticipated base pay range for this position is $88,000 to $141,450. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below.
https://www.careers.jnj.com/employee-benefits
QualificationsRequired Qualifications:
Minimum of a Bachelor's Degree required, Advanced Degree highly desired; desired areas of study include Science, Engineering, or related field.
Minimum of 4+ years of related Regulatory Affairs experience within Medical Device is required (3+ 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 J&J 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.
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.
Preferred Qualifications:
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 Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit
www.careers.jnj.com .
#J-18808-Ljbffr