In joining our growing regulatory team, the Sr. Regulatory Affairs Program Lead 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:

• 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.

The anticipated base pay range for this position is $104,000 to $166,750. 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

Qualifications

Required Qualifications:

• 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 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.

• 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.

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.