Olympus Corporation of the Americas Regulatory Affairs Manager in Westborough, Massachusetts
Working Location: MASSACHUSETTS, WESTBOROUGH
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.
Let’s inspire healthier lives, together.
The Regulatory Affairs Manager is responsible for managing the US FDA submissions for medical devices commercialized by Olympus America Inc. (OAI), as well as managing a team of Regulatory Professionals. The individual will be involved in co-developing and implementing regulatory strategies, preparing and managing the preparation of submissions, staying up-to-date on FDA regulations and guidance documents, and interacting with the FDA. This position will regularly work together with other departments outside of the U.S. (e.g., regulatory affairs; R&D), as well as interact with the FDA.
Manage FDA submissions based on the project list and its priorities.
Develop regulatory submission strategies in collaboration with the RA Director and project teams, support and implement these strategies to develop successful regulatory submission plans.
Manage the team of regulatory professionals, and support their development, coaching and mentoring.
Coordinate, compile, submit organized and scientifically valid submissions to the FDA (i.e., 510(k), 513(g), pre-submissions, IDE, etc.). Prepare responses to all FDA inquiries on submitted 510(k)s, working with the M-BCs, to ensure successful 510(k) clearance.
Working with the regulatory team, RA Director, and Olympus staff outside of the U.S., coordinate schedules and resources necessary for timely completion of projects.
Develop strong working relationships with Olympus counterparts, both within Regulatory Affairs and other departments, in order to motivate and influence cross-functional groups to accomplish project-related objectives.
Build strong rapport and interface with regulatory agency.
Act as regulatory SME on project teams and/or working groups, bringing acquired technical expertise as well as regulatory expertise to these teams to provide guidance.
Interpret regulations, guidances/policies; communicate existing policies and changes in the regulatory environment to RA staff outside of the U.S., and provide guidance and training when required.
* Bachelor's degree, preferably in a scientific discipline.
Minimum of 10 years of experience in regulatory affairs, and at least 5 years of experience in a technical field (e.g., engineering, R&D, microbiology, Quality Assurance).
Submission writing with focus on FDA submissions (i.e., 510(k), Pre-Submissions, De Novo, IDE, PMA/PMA Supplement).
Participation in setting up submission strategies, working with new product development teams.
Minimal travel (5%, domestic and international).
* Experience working with global teams.
Excellent communication skills (written, oral).
Able to transfer technical experience into regulatory submissions (preparation, communication with teams, document review, submission writing, discussion with regulator, etc).
High level of attention to detail.
Problem solving skills.
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.
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.
Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com .
Olympus…True To You. True To Society. True To LIFE.
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.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough ||
Olympus Corporation of the Americas
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