Olympus America Inc. Specialist, Sr. Reg. Affs. in Redmond, Washington
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
Bachelor's Degree or equivalent degree in science, engineering or related fields is required; Currently enrolled in or graduate of a life sciences regulatory affairs degree or certificate program highly preferred.
Minimum of 8 years working in regulatory affairs is required.
Minimum of 5 years progressively responsible experience working on medical device submissions to the FDA is required.
Knowledge of FDA medical device regulations and guidance, Medical Device Directive (93/42/EEC) and guidance, ISO 13485 Quality System standard, and other applicable US and international regulations, guidances, and standards is essential.
Independent experience with regulatory submissions is necessary: ideally 510 (k), IDE and/or PMA submissions, and ideally also with submissions outside the US, including EU.
Ability to think critically, using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems is essential.
Must have high level of proficiency in Microsoft Word, Outlook, Excel and PowerPoint.
Visio skills are desired.
Excellent writing and English grammar skills are necessary.
Ability to think strategically and coordinate across cross-functional teams is essential.
Proven record of consistently following through on commitments is desired.
Proven record of maintaining and communicating realistic schedules and meeting or beating deadlines is necessary.
Must have service oriented approach, flexible and proactive towards changing needs.
Exceptionally team focused and actively contributes to a positive and innovative work environment is necessary.
Proven ability to work on assignments that are complex and sensitive in nature where independent action and initiative are required in resolving problems and developing recommendations is essential.
Must work precisely according to procedures, rules and regulations; has a passion for continuous improvement and quality. Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.
Ability to occasionally work overtime, including evenings is preferred.
Must be willing to travel at least twice per year for training/meetings.
In collaboration with regulatory team, support US and OUS (Outside US) regulatory submissions. Includes assessment, creation, preparation, and submission of organized and scientifically valid regulatory and clinical study submissions in the US (IDE, PMA, 510(k), HDE) and OUS (submissions to Ethics Boards, Health Authorities, and Notified Bodies) and ongoing maintenance as required.
Respond to regulatory authorities’ requests for additional information Interface with international regulatory authorities and notified bodies as necessary to assure company products comply with country requirements.
Participate on cross-functional product development teams to advise on regulatory aspects of project.
Assist with maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management.
Develop regulatory strategies including identifying predicate devices.
Assist with device labelling reviews. Review and draft as assigned: clinical investigational plans, investigator brochures, informed consent, instructions for use, case report forms, change summaries, product labelling and technical documentation, quality system/manufacturing documentation, verification/validation documentation, risk management documentation, and marketing/promotional material.
Write and/or edit associated project and device documentation.
Review and approve document change notices for associated regulatory impact and risk.
Keep abreast of changes and proposed changes to the worldwide regulatory requirements related to our products and processes.
Advise regulatory management of changes and as appropriate communicate regulatory initiatives or changes to other team members.
Execute other regulatory projects, as required.
Perform all other essential duties as assigned.
The team at Olympus Respiratory America designs, manufactures and markets diagnostic and therapeutic medical devices that complement the Olympus bronchoscopic and endoscopic platforms. Our mission is to advance the standard of care for physicians treating diseases though innovative, clinically driven, high value products. Olympus Respiratory is located in the beautiful Pacific Northwest in the high-tech hub of Redmond, Washington. Our organization has established itself as a center for engineering excellence within Olympus: We enjoy working in a small, innovative collaborative environment with the added advantage of being supported by a global technology-driven organization. We are continuing to build a team committed to a common mission and motivated by the opportunity to make a significant contribution to the health and well-being of others.
Redmond, WA - The Sr. Regulatory Affairs Specialist provides a wide variety of support to the Regulatory Affairs department including execution of projects and deliverables in the pursuit of obtaining approval to market ORA medical devices in the worldwide markets served.
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 Respiratory at http://www.olympusrespiratory.com/
Senior Regulatory Affairs Specialist
Reg Affairs/Quality Assurance
Redmond, WA ORA
Auto req ID:
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.