RA Specialist II

Olympus Corporation; Boston (MA); Hybrid; USD 70,000 - 95,000; Full time

Benefits offered by this job

Competitive salaries

Annual bonus

401(k) with company match

Comprehensive medical, dental, vision coverage

Paid vacation and sick time

Paid parental leave

On-Site Child Daycare

Job summary

Olympus Corporation is hiring for a Regulatory Affairs role based in Massachusetts. The successful candidate will assist in obtaining marketing approvals and provide regulatory input for new product developments.

Candidates should have at least 3 years of regulatory affairs experience in the Medical Device industry, preferably with a BS/BA in engineering or life sciences. Olympus offers a hybrid work environment and a comprehensive benefits package including medical coverage, paid vacation, and 401(k) matching.

Qualifications

• Minimum 3 years of regulatory affairs experience in the Medical Device industry with BS/BA or 1 year with MS preferred.

Responsibilities

• Assist Manager Regulatory Affairs in obtaining marketing approval for Olympus medical devices.
• Participate in product teams developing new products.
• Develop and maintain US medical device submissions such as 510(k)s.
• Interface with international teams for regulatory submissions.

Skills

Regulatory affairs experience

Medical Device industry knowledge

Engineering or life sciences background

RAC accreditation

Education

BS/BA in engineering or life sciences

Job description

Working Location: Massachusetts, Westborough; Minnesota, Brooklyn Park; Pennsylvania, Center Valley

Workplace Flexibility: Hybrid

Job Description

Assist 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 510(k)s 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 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.
• RAC accreditation a plus.

Benefits

• 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.

Equal Employment Opportunity

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.