Olympus Corporation of the Americas Senior Regulatory Affairs Manager in Redmond, Washington
Working Location: Nationwide; WASHINGTON, REDMOND
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.
Assist the Head of Regulatory Affairs with daily management of all regulatory affairs activities. Working with Regulatory Affairs and Clinical Operations staff help develop and implement strategies for the earliest possible clinical study and product approvals. Ensure the timely creation preparation and achievement of organized and scientifically valid regulatory and clinical trial submissions.
In a typical day, you will:
Assist with the development and implementation of regulatory plans and strategies for US and international clinical studies product and export approvals with regulatory quality and international marketing staff as well as Olympus affiliates and outside consultants (regulatory clinical biostatistics quality).
Provide guidance and training to project team department and company based on current regulatory affairs requirements regulations and processes; provide also for external personnel as required.
Create prepare and submit organized and scientifically valid regulatory and clinical trial submissions in the US (IDE PMA 510(k) HDE) and OUS (submissions to Ethics Boards Health Authorities Notified Bodies).
Build a strong rapport and interface with regulatory agencies.
Review and understand and help draft as necessary: clinical investigational plans investigator brochures informed consent instructions for use case report forms change summaries product labeling and technical documentation quality system/manufacturing documentation verification/validation documentation risk management documentation and marketing/promotional material.
Review and approve all document changes for associated regulatory impact and risk.
Create and ensure maintenance/archive of paper and electronic regulatory documents internally (correspondence regulatory submissions and approvals).
Proactively research and maintain current relevant regulatory information (i.e. guidance's CFR references etc.) distill the important sections that apply to the company and assist the Head of Regulatory Affairs in recommending appropriate company compliance.
As directed interact with outside consultants and contractors that directly relate to job responsibilities (communication scheduling project status budgets/invoices).
Perform other duties as necessary and assigned.
Bachelor's. degree in science engineering or related fields.
Minimum of seven years US regulatory affairs experience in the medical device industry.
High level of proficiency in Microsoft Word Outlook Excel and PowerPoint required.
Ability to work overtime including evenings on occasion.
Potential infrequent travel, domestic and international.
Advanced Degree and/or RAC CQA and CQM.
International regulatory experience preferred.
Excellent knowledge of FDA medical device regulations and guidance.
Medical Device Directive (93/42/EEC) and guidance.
Good Clinical Practices guidance.
ISO 13485 Quality System standard and other applicable.
US and international regulations guidance's and standards.
Proven ability to implement the above regulations standards and guidance's in the medical device industry.
Strong regulatory affairs experience related to US Class III medical devices.
Proven expertise with original 510(k) IDE and/or PMA submissions paper-based and electronic versions.
Proven expertise in international registrations – particularly CE marks and notified body audits.
Proven expertise in quality system development/implementation and both internal and 3rd party/FDA audits.
Good knowledge of product and process verification and validation and risk management.
Visio skills desirable.
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 at https://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) || Washington (US-WA) || Redmond ||