Regulatory Affairs Specialist II - Medical Devices

Olympus Corporation of the Americas; Westborough (MA); Hybrid; USD 91,000 - 123,000; Full time

Benefits offered by this job

Competitive salary

401(k) with match

Medical/dental/vision coverage

Paid time off

Parental leave

On-site facilities

Job summary

Olympus Corporation of the Americas is seeking a Regulatory Affairs professional to assist the Manager Regulatory Affairs in obtaining approvals to market Olympus medical devices in the markets we serve. Hybrid roles span Massachusetts, Minnesota and Pennsylvania with on-site and remote collaboration.

You will participate in global regulatory strategies, prepare US 510(k)/Pre-Submissions, and interface with EU and other international teams to support registrations.

Qualifications

• Regulatory affairs experience in the Medical Device industry is mandatory [minimum 3 years with BS/BA or 1 year with MS preferred].
• RAC accreditation a plus.

Responsibilities

• 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.
• Develop, coordinate, prepare and maintain US medical device submissions such as 510(k)s and Pre-Submissions and liaise with FDA reviewers as needed.
• Develop, coordinate, prepare and maintain medical device submissions for Canadian Class 2/3/4 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 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.
• Assist in the development and maintenance of regulatory procedures to assure consistent efficient and compliant regulatory processes.

Skills

Regulatory affairs

Education

BS/BA in engineering or life sciences

MS preferred

Job description

Olympus Corporation of the Americas is seeking a Regulatory Affairs professional to assist the Manager Regulatory Affairs in obtaining approvals to market Olympus medical devices in the markets we serve. Hybrid roles span Massachusetts, Minnesota and Pennsylvania with on-site and remote collaboration.

You will participate in global regulatory strategies, prepare US 510(k)/Pre-Submissions, and interface with EU and other international teams to support registrations.