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Regulatory Affairs Specialist

Req ID:  4708

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

Assist the manager Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus.

Job Duties

* Participate in product teams developing new products.

 

* As needed provide input to define global regulatory strategy requirements.

 

* Participate in teams for sustaining products to provide input on global regulatory requirements.

 

* Where designated, develop coordinate prepare and maintain US medical device submissions such as 510ks and Pre-Submissions and liaise with FDA reviewers as needed.

 

* Where designated, develop coordinate prepare and maintain medical device submissions for Canadian Class 2, 3, or 4 Device License submissions.

 

* Respond 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.

 

* Where designated 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.

 

* Assist with maintenance of regulatory files and databases to ensure prompt and accurate access to company regulatory information.

 

* Provide dashboard updates concerning current pending and future approvals for Regulatory Affairs management.

 

* As needed assist in the development and maintenance of regulatory procedures to assure consistent efficient and compliant regulatory processes.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor's degree required preferably in engineering or life sciences. 

 

* RAC accreditation a plus.

 

* Regulatory affairs experience in the Medical Device Industry is mandatory (minimum 3 years with Bachelor's or 1 year with Master's preferred).

 

#LI-LR1

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 requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.

 

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: QA, Quality Assurance, Engineer, Quality, Technology, Engineering

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