Working Location: Massachusetts, Westborough; Minnesota, Brooklyn Park; Pennsylvania, Center Valley Workplace Flexibility: HybridJob DescriptionAssist the Manager Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus
Job Duties- Participate in product teams developing new products.
- As needed, provide input to define global regulatory strategy requirements.
- Participate in teams for sustaining products to provide input on global regulatory requirements.
- Where designated, develop coordinate prepare and maintain US medical device submissions such as 510ks and Pre-Submissions and liaise with FDA reviewers as needed.
- Where designated, 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.
- Where designated, interface with the EU Submissions Team to support preparation of dossiers and technical files for registration of Olympus products in the EU.
- Where designated, interface with International Regulatory Affairs Team to support preparation of dossiers for registration for 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.
- As needed, assist in the development and maintenance of regulatory procedures to assure consistent efficient and compliant regulatory processes.
Job QualificationsRequired:- 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.
- RAC accreditation a plus.
Why join Olympus?We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.
Equitable Offerings you can count on:- Competitive salaries, annual bonus and 401(k)* with company match
- Comprehensive medical, dental, vision coverage effective on start date
- 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**
Connected Culture you can embrace:- Work-life integrated culture that supports an employee centric mindset
- Offers onsite, hybrid and field work environments
- Paid volunteering and charitable donation/match programs
- Employee Resource Groups
- Dedicated Training Resources and Learning & Development Programs
- Paid Educational Assistance
*US Only
**Center Valley, PA and Westborough, MA
Are you ready to be a part of our team?Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks.
The anticipated base pay range for this full-time position in this location is $91,148.00 - $123,049.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements).
Olympus considers a variety of factors when determining actual compensation for this position, including level of experience, working location, and relevant education and certifications.
