Olympus America Inc. Director, Regulatory Affairs in Southborough, Massachusetts
As a Regulatory Expert working on the OSTA-RA team, you will be empowered and inspired to do your best work. You will contribute to our mission by supporting the organization’s goals and objectives, our customers within Olympus, patients, and the medical community. In a typical day, you will:
Facilitate development of regulatory strategies for new product development projects, novel technologies or market segments. Interface with International Regulatory Affairs Team to ensure global planning considerations are included in regulatory strategy development.
Oversee and facilitate communication of these strategies to product teams responsible for developing new products.
Maintain responsibility for overseeing development, coordination, preparation and maintenance of US medical device submissions such as Pre-Submissions, 510ks, PMAs, IDEs and applicable supplements and annual reports and liaise with FDA reviewers as needed.
Assist OSTA RA management by liaising with other Olympus (MBC) groups to provide/ share US regulatory expertise in developing project regulatory strategy and 510(k) submission support.
Where designated, maintain responsibility for development, coordination, preparation and maintenance of medical device submissions for Canadian Class 2, 3 or 4 Device License submissions. Lead development of responses to regulatory authorities’ requests for additional information.
As needed, responsible for review and approval of product labelling (including IFU) and other ancillary labelling-related matters.
Facilitate team interaction with Upstream Marketing, R&D, and Operations in developing labelling materials.
Maintain responsibility for overseeing maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information and to provide reports to regulatory and business management concerning current, pending, and future product approvals.
Maintain responsibility for keeping abreast of changes and proposed changes to the worldwide regulatory requirements related to our products and processes.
May be tasked to formally advise regulatory and business management of changes and as appropriate communicate regulatory initiatives or changes to other OSTA staff.
Maintain responsibility for the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes.
Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day. We’re currently looking for a Director of Regulatory Affairs to join us in our Southborough, MA office.
Let’s inspire healthier lives, together.
The Directory, Regulatory Affairs will lead the Core Submissions Regulatory Affairs Team and provide world-class regulatory services to Olympus Group 1 Markets. The incumbent will support the Executive Director, Regulatory Affairs, to plan and direct Core Regulatory Affairs Team activities, including but limited to: analysis of strategic requirements and resource allocation to support of new product development teams, preparation and submission of regulatory documentation for product registration/licensing in selected markets. The position requires interaction and liaison with Olympus PDP team management and businesses leaders, for introduction of Gyrus ACMI devices to the respective markets. He/She will also be responsible for oversight, and where necessary, interaction with the respective Group 1 Market regulatory agencies.
Oversee a team of Regulatory Affairs professionals located in several of the Olympus facilities within the Americas.
Establish performance and career development goals for the team personnel, and guide them to successful achievement.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
At Olympus, we put a lot of good back into the world, and what we do really matters. We are committed to making people’s lives healthier, safer and more fulfilling every day by crafting innovative optical and digital solutions in medical technologies, microscopy, industrial solutions, cameras, and audio recorders.
We view our relationship with and commitment to our employees with the same passion. Everything we do at Olympus is a reflection of our vision, and everyone here helps to make it a reality. We’re invested in our employees, great ideas, and how they impact the communities around us. We see the world through multiple lenses and come together to find the right answers; the best solutions.
TRUE TO YOU. TRUE TO SOCIETY. TRUE TO LIFE.
Olympus Surgical Technology America
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
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
Bachelor's Degree is required, preferably in Engineering or Life Sciences; RAC accreditation and Advanced Degree are preferred.
Minimum of 15 years of Regulatory affairs experience in the Medical Device industry is required; OR, a minimum of 10 years experience with Master's Degree is required.
Experience with Combination products and/or PMA devices is preferred.
Olympus Surgical Technology America at http://www.olympus-osta.com/
Director, Regulatory Affairs
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.