Regulatory Affairs Manager, Digital

**Key Responsibilities**:

- Lead, Direct, and coordinate activities concerned with the submission and approval of products to government regulatory agencies.
- Provide mentorship to project team members regarding regulatory compliance issues.
- Lead all aspects of the preparation and maintenance of regulatory submissions and files.
- Establish accountability for the preparation of vital outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Ensure adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.
- Collaborate with management personnel to establish and prepare appropriate regulatory filings for product approvals.
- Ensure organizational compliance with all applicable regulations and J&J policies.
- Assign projects or activities, provide day-to-day instructions, and suggested training activities to direct reports (if any).

**Qualifications**
Education**:

- A minimum of Bachelor’s Degree in a scientific, engineering, business, or legal disciple is required (Master’s and/or PhD desired)
- At least 6 years of regulatory experience (4 years with Master’s and 3 years with PhD)
- Experience with US and European medical device regulatory processes required
- Proven track record of developing and implementing global regulatory strategies that align with business results
- Leadership experience

**Preferred Skills & Experience**:

- Knowledge of Digital technologies including SaMD, SiMD, Robotics, etc., desired
- Experience working with professional and trade associations
- Experience in preparing and submitting US regulatory files (510(k)s, PMAs) as well as European Technical Files and Design Dossiers
- Must have excellent written, verbal communication and presentation skill required. People management experience preferred.

**Other**:
Remote work options may be considered on a case-by-case basis and if approved by the company.

The base pay range for this position is $106k to midpoint $160K.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus. 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 may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

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.

**Primary Location**
United States
- **Other Locations**
Europe/Middle East/Africa, North America-United States-Pennsylvania-West Chester, Europe/Middle East/Africa-Switzerland-Basel-Country-Oberdorf, Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil, United States-Indiana-Warsaw
**Organization**
Medical Device Business Services, Inc (6029)
**Job Function**
Regulatory Affairs
**Requisition ID**
2206003432W