At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Career Programs **Job Sub** **Function:** Non-LDP Intern/Co-Op **Job Category:** Career Program **All Job Posting Locations:** US345 MA Danvers - 22 Cherry Hill Dr **Job Description:** Johnson & Johnson is currently seeking a **Regulatory Affairs Co-op** to join our **Regulatory Affairs Team** located in **Danvers, MA.** At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the **breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at** https://www.jnj.com/ (https://url.us.m.mimecastprotect.com/s/MR\_SCqxD2Oivo14wsZygBQ?domain=jnj.com/) **.** **Requirements:** Our Regulatory Affairs Team supports Abiomed in navigating complex regulatory landscapes to bring the latest innovations in Heart Recovery to our patients. We are looking for a Co-op who will be fully integrated as a member of our team, achieving global regulatory approvals, registrations, and licenses for our products and services while ensuring compliance with global regulations and internal procedures. The Regulatory Affairs Co-op will: + Assist in completing/documenting global regulatory assessments for changes to medical devices + Attend project team meeting with Regulatory Affairs Lead + Prepare and maintain Regulatory Affairs data and metrics + Evaluate current processes and propose opportunities for internal efficiencies + Compile and/or write regulatory dossiers for global submissions **Qualifications:** + Junior, Senior, or Graduate student pursuing a degree in Mechanical Engineering, Biomedical Engineering, or directly related discipline. + Demonstrated communication skills, both written and verbal + Knowledge of medical device regulations (e.g., US and EU) + Motivated self-starter who is keen to build regulatory knowledge + Team player _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._ _The anticipated base pay for this position is between 22$ per hour and 51.50$ per hour but will be based on candidate's program year, discipline, degree and/or experience. This position is overtime eligible. Intern/Co-ops may be eligible to participate in Company employee benefit programs such as medical insurance, sick time, holiday pay, and the Company’s consolidated retirement plan in accordance with the terms of the applicable plans. Housing stipend will be offered for those that qualify. This position is ineligible for severance. For additional general information on Company benefits, please go to:_ _https://www.careers.jnj.com/employee-benefits_ 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 and 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 email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. **The anticipated base pay range for this position is :** 22$ per hour to 51.50$ per hour Additional Description for Pay Transparency: The anticipated base pay for this position is between 22$ per hour and 51.50$ per hour but will be based on candidate's program year, discipline, degree and/or experience. This position is overtime eligible. Intern/Co-ops may be eligible to participate in Company employee benefit programs such as medical insurance, sick time, holiday pay, and the Company’s consolidated retirement plan in accordance with the terms of the applicable plans. Housing stipend will be offered for those that qualify. This position is ineligible for severance. For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits