Regulatory Affairs Specialist I – Spine

Qualifications

Education:

• Minimum of a bachelor’s degree required, advanced degree strongly preferred.  Desired fields of study include science, engineering (e.g., biomedical, electrical, software, mechanical), business, legal, or similar.

Experience and Skills:

• Experience in a highly regulated industry preferred, preferably with medical devices.  Relevant internship experience may be considered.
• Demonstrated intellectual capacity to identify, read, understand, and address global medical device regulations are required.
• Experience in the preparation and submission of US regulatory filings (e.g., 510(k), PMA) as well as European technical files and design dossiers is strongly preferred.
• Knowledge of US and European regulatory processes is preferred.
• Must have excellent written, verbal communication, and presentation skills.

Other:

This position will be located in Raynham, MA, and may require up to 10% domestic and international travel.

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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 based on 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.

Required Skills:

Preferred Skills:

The anticipated base pay range for this position is :

$64,000.00 - $102,350.00

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)).

This position is eligible to participate in the Company’s long-term incentive program.

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