Regulatory Affairs Spring Co-op

Regulatory Affairs Co-Op

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness.

We are searching for the best talent in Regulatory Affairs. This position is on site on our Cincinnati, OH campus.

Regulatory affairs professionals support the development, testing, manufacturing and marketing of healthcare products to provide the safest, most effective and highest-quality medical devices, pharmaceuticals, biologics, diagnostics, and digital health for patients and the public at-large. A trained Regulatory Affairs Specialist provides regulatory guidance to project teams in strategic planning and related submissions to support Johnson & Johnson products.

In this role the co-op associate will be exposed to practices to develop and execute regulatory strategy for new products and significant changes for the US and Global markets, to support product launches and continued commercialization of products in key countries. The co-op may create processes to helps define data and information needed for regulatory actions in conjunction with cross-functional teams. He / she guides conformance with applicable regulations through the development of best practices for Regulatory Affairs processes, procedures and systems.

Key duties may include :

• Ensures compliance with regulatory agency regulations and interpretations.
• Assist with the preparation for responses to regulatory agencies' questions and other correspondence.
• Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
• Provides solutions to a variety of problems of moderate scope and complexity.
• Researches and collects data; and responds to requests from regulatory agencies and / or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates
• Support internal and external audit activities
• Research and assist in the development of best practices for Regulatory Affairs processes, ultimately leading to expedited product to the patient, nurses and surgeons
• Represent Regulatory Affairs throughout the business including cross-functional project teams

Permanently authorized to work in the U.S., must not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually requires future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship.

Ineligibility for Severance.

The expected pay range for this position is between $23.00 per hour and $51.50 per hour but will be based on candidate's program year, discipline, degree and / or experience. Co-Ops / Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits : up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year. Co-Ops and Interns are eligible to participate in the Company's consolidated retirement plan (pension).

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 or contact AskGS to be directed to your accommodation resource.