Olympus America Inc. Mgr., Assoc. Territory - Intl RA in Southborough, Massachusetts
Assist in the preparation of global registration dossiers to obtain product registrations in Olympus regional markets worldwide.
Support specific regions or key markets depending on work plans.
Support team’s daily operations of regulatory processes to ensure compliance with routine regulatory reporting obligations.
Obtain Certificates of Export from FDA, or other applicable export notifications as needed.
Support maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information concerning current, pending, and future approvals and renewals.
Provide progress of work-plans and the status of key project deliverables.
Support liaison with Olympus S-BCs and local distributors to coordinate, develop and maintain international submissions.
Assist with reviewing of product and process documentation for assigned projects to ensure compliance with change control requirements to aid in determining if regulatory submissions are required.
Provide assistance in keeping abreast of changes and proposed changes to the worldwide regulatory requirements related to company products and processes.
Provide assistance in advising regulatory management of changes, and as appropriate, aid the communication of regulatory initiatives or changes to company members.
As needed, assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes.
Facilitate compliance activities related to global regulations and international standards.
Assist Director, Intl RA and Executive Director, RA during inspections by International Regulatory Agencies.
Partner with development, coordination, preparation and maintenance of \"Core International\" medical device submissions such as EU design dossiers & technical files and Canadian submissions.
Perform all other essential related duties as required.
Southborough, MA or Field - The Associate Territory Manager, International Regulatory Affairs will support international regulatory affairs activities, including but not limited to: assisting in providing international regulatory expertise to new product development and sustaining engineering team’s preparation and submission of regulatory documentation for product registration/licensing in selected global markets.
Olympus embraces diversity and inclusion. As an Equal Opportunity Employer, our policies as well as our values prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification. EOE Minorities/Females/Veterans/Disabled
At Olympus, we are True to You!
Olympus Surgical Technology America is a dynamic medical device company whose vision is to anticipate the needs of surgeons through powerful see and treat procedure solutions that are safe, simple, cost efficient and produce the highest quality patient outcomes. Olympus Surgical Technology America is focused on Minimally Invasive procedures in Urology, Gynecology, General Surgery and ENT. Olympus Surgical Technology America believes its people are its greatest asset. We offer an environment that challenges everyone to grow, contribute, excel and share successes. Olympus Surgical Technology America is committed to creating a world class company with world class people. Olympus Surgical Technology America
(ONLY QUALIFIED APPLICANTS WILL BE CONSIDERED)
Bachelor's Degree is required, preferably in engineering or life science; Master's Degree is preferred.
Minimum of 3 years of Regulatory Affairs experience in the Medical Device industry is required; if Master's, minimum of 1 year is required.
Olympus Surgical Technology America at http://www.olympus-osta.com/
Associate Territory Manager, International Regulatory Affairs
Reg Affairs/Quality Assurance
Southborough GYR ACMI Inc
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Olympus is an Equal Opportunity Employer, and our policies prohibit unlawful discrimination based on an employee's or applicant's race, color, sex, age, physical or mental disability, national origin, religion, sexual orientation, gender identity and/or expression, marital status, genetic information, ancestry, military or veteran status, or any other federal, state or local protected classification.