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Program Regulatory Affairs Manager

Req ID:  298

Working Location: MASSACHUSETTS, SOUTHBOROUGH 

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 Regulatory Affairs Manager assists the Regulatory Affairs Manager in obtaining approval to market Olympus medical devices in the markets served by Olympus.

Job Duties

In a typical day, you will:

* 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.

* Maintain responsiblity 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. 

* Maintain responsibility 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. 

* Maintain responsibility 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. 

* Maintain responsibility 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. 

* Perform other duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS:

* Minimum 10 years with a bachelors in Regulatory affairs experience in the Medical Device industry is mandatory. Minimum 7 years with Master's 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

* Bachelor's required, preferably in engineering or life sciences.  RAC accreditation or Post-graduate degree preferred.

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.

 

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

 

Posting Notes: || United States (US) || Massachusetts (US-MA) || Southborough || 


Nearest Major Market: Worcester

Job Segment: Engineer, Manager, Business Development, Marketing Manager, Business Manager, Engineering, Management, Sales, Marketing

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