RA Specialist II

Working Location: Massachusetts, Westborough; Minnesota, Brooklyn Park; Pennsylvania, Center Valley Workplace Flexibility: Hybrid Job Duties Assist the Manager Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus. Participate in product teams developing new products. Provide input to define global regulatory strategy requirements as needed. Participate in sustaining product teams to provide input on global regulatory requirements. Develop, coordinate, prepare and maintain US medical device submissions such as 510k and Pre‑Submissions and liaise with FDA reviewers as needed. Develop, coordinate, prepare and maintain medical device submissions for Canadian Class 2, 3 or 4 Device License submissions. Respond to regulatory authorities' requests for additional information. Interface with the EU Submissions Team to support preparation of dossiers and technical files for registration of Olympus products in the EU. Interface with the International Regulatory Affairs Team to support preparation of dossiers for registration in other international markets such as Japan, the Far East, Australia and Latin America. Assist with maintenance of regulatory files and databases to ensure prompt and accurate access to company regulatory information. Provide dashboard updates concerning current pending and future approvals for Regulatory Affairs management. Assisted in the development and maintenance of regulatory procedures to assure consistent efficient and compliant regulatory processes. Job Qualifications Required: Regulatory affairs experience in the Medical Device industry is mandatory (minimum 3 years with BS/BA or 1 year with MS preferred). Preferred: BS/BA required, preferably in engineering or life sciences. Benefits Competitive salaries, annual bonus and 401(k) with company match. 24/7 Employee Assistance Program. Free live and on-demand Wellbeing Programs. Generous Paid Vacation and Sick Time. Paid Parental Leave and Adoption Assistance. 12 Paid Holidays. On‑Site Child Daycare, Café, Fitness Center. Applicants Requesting Accommodations: Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact View email address on click.appcast.io. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1‑888‑Olympus View phone number on click.appcast.io). It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law. Posting Notes: United States (US) | Massachusetts (US-MA) | Westborough | Quality & Regulatory Affairs (QA/RA) #J-18808-Ljbffr Olympus Corporation of the Americas