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Regulatory Affairs Program Manager

Req ID:  2434

Working Location: Washington, Seattle 

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.

Job Description

Regulatory Affairs Program Manager will support the organization in obtaining and maintaining market approval of Olympus medical devices in the markets served by Olympus.

Job Duties

* Facilitate development of regulatory strategy for novel technologies or market segments, that lead to product teams responsible for developing new products.

 

* Where tasked by Regulatory Management, assist with Business Development opportunities, including due diligence assessments of regulatory posture, research, and capabilities.

 

* Responsible for 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.

 

* Where designated, responsible for development, coordination, preparation, and maintenance of medical device submissions for Canadian Class 2, 3 or 4 Device License submissions and EU class 1s, IIa, IIb, orIII medical devices under Regulation (EU) 2017/745.

 

* Lead development of responses to regulatory authorities’ requests for additional information. Interface with International Regulatory Affairs Team to support preparation of dossiers for registration for other international markets such as Japan, the Far East, Australia, and Latin America.

 

 

* Keep abreast of changes and proposed changes to the worldwide regulatory requirements related to our products and processes. May be tasked to advise management of changes, and as appropriate, communicate regulatory initiatives or changes to other OSTA Staff.

 

* Responsible for 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.

 

* Where designated, review and provide input to clinical related documentation, including clinical investigational plans, investigator brochures, informed consent, instructions for use, and case report forms.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree equivalent degree in science, engineering, or related fields.

 

* Minimum of 10 years working in medical device industry.

 

* Minimum of 7 years progressively responsible experience working on US/EU medical device submissions

 

*  Direct experience working and collaborating with Regulatory Authorities.

 

* High level of proficiency in Microsoft Word, Outlook, Excel and PowerPoint required.
 

PREFERRED QUALIFICATIONS: 

 

* RAC, CQA, and CQM accreditation preferred.

 

*  Science or engineering course of study optimal.

 

* Knowledge of FDA medical device regulations and guidance, Medical Device Regulation (EU) 2017/745, ISO 13485 Quality System standard, and other applicable US and international regulations, guidances, and standards.

 

* Proven expertise with regulatory submissions: 510(k), IDE and/or PMA submissions, and submissions outside the US, including EU.

 

* Visio skills are 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.

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 || 


Nearest Major Market: Seattle
Nearest Secondary Market: Bellevue

Job Segment: Program Manager, Engineer, Manager, Business Development, QA, Management, Engineering, Sales, Quality

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