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Program Manager, Regulatory Affairs

Req ID:  2326

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.

Job Description

The Program Manager, Regulatory Affairs will assist the manager in obtaining approval to market 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 review and approval of product labeling (including IFU) and other ancillary labeling-related matters.

 

* Work closely with Upstream Marketing and the Regulatory Labeling Team in developing labeling materials. 

 

* 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. 

 

* Lead development of responses to regulatory authorities’ requests for additional information.

 

* Where designated, interface with the EU Submissions Team to support preparation of dossiers and technical files for registration of Olympus products in the EU.  

 

* 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. 

 

* Responsible 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. 

 

* 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. 

Job Requirements

REQURIED QUALIFICATIONS:
 

* Regulatory affairs experience in the Medical Device industry is mandatory with a minimum 10 years and a  BS/BA or 7 years with MS is preferred

 

* Regulatory affairs experience in writing US submissions and EU submissions is mandatory and experience in collaboration and working with the Regulatory Authorities directly is mandatory

 

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 || 


Nearest Major Market: Worcester

Job Segment: Program Manager, Manager, Marketing Manager, Business Development, Business Manager, Management, Marketing, Sales

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