Olympus America Inc. Mgr., Assoc. Program - Intl RA in Southborough, Massachusetts
Manage the development and maintenance of international regulatory program systems and processes.
Manage the preparation and maintenance of international product registrations requiring governmental/regulatory agency approval by identifying, monitoring and managing global registration requirements and identifying potential risks to existing and future business.
Provide expertise and guidance on these requirements to cross-functional new product development teams.
Partner with NPD Core Team members to develop global product registration strategies and implement company business plans.
Establish effective working relationships to liaise with product development teams to develop, coordinate, prepare and maintain deliverables essential to supporting regulatory submissions.
Establish effective working relationships to liaise with Olympus S-BCs and local distributors to develop regulatory strategies to support the development and maintenance of regulatory submissions.
Review product and process documentation for assigned projects to ensure compliance with change control requirements and determining whether regulatory submissions are required.
Exercise judgement in the oversight of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information.
Represent the OSTA International RA Team, and/or where designated, the OSTA RA Department, in communicating regulatory initiatives or changes by leading global regulatory discussions within the organization, and with global regulatory authorities.
Provide identification of budgetary needs for the International RA team to the Director Intl RA Develop and facilitate the effective management of the process for obtaining and maintaining Certificates of Export from FDA, or other applicable export notifications as needed.
Perform all other essential related duties as required.
Southborough, MA or Field - The Associate Program Manager will support Regulatory Affairs in obtaining approval to market Gyrus ACMI medical devices in the worldwide markets. The incumbent will manage international regulatory affairs activities and provide world-class regulatory services to Olympus Sales Business Centers (SBC’s) and distributors. He/She will partner with the core regulatory team in development, coordination, preparation and maintenance of global product registration strategies and registration documentation. The incumbent will apply advanced technical expertise and uses skills to contribute to the development of company objectives and principles that achieve goals in creative and effective ways. He/She will be required extensive interaction and strong liaison with Gyrus ACMI development and Olympus SBC teams for the introduction of Gyrus ACMI devices to the respective 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 CANDIDATES WILL BE CONSIDERED)
Bachelor's Degree is required, preferably in Engineering or Life Sciences; Post-Graduate degree is preferred.
RAC accreditation is preferred.
Minimum of 7 years Regulatory affairs experience in the Medical Device industry is required; if Advanced Degree, a minimum of 5 years experience is required.
Olympus Surgical Technology America at http://www.olympus-osta.com/
Associate Program 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.