Senior Regulatory Affairs Specialist (OTTAVA)

You will be responsible for:

• 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.

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 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.
• Previous experience with health authority meetings/interactions preferred.
• Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and their documentation in submissions preferred.

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.

#LI-Hybrid

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Behavior, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Legal Support, Medicines and Device Development and Regulation, Problem Solving, Product Licensing, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Teamwork

The anticipated base pay range for this position is :

$92,000.00 - $148,350.00

For Bay Area:

$106,000.00 - $170,200.00

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