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RA Program Manager

Req ID:  2988

Are you looking for a company that cares about people’s lives and health, including yours?

 

Olympus is passionate about creating customer-driven solutions for the medical, life sciences, and industrial equipment industries. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Job Description

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

Job Duties

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


* 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 or4 Device License submissions and EU class 1s, IIa, IIb, orIII medical devices under Regulation (EU) 2017/745. Lead development of responses toregulatory authorities’ requests for additional information. Interface with International Regulatory Affairs Team to support preparation of dossiers forregistration 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 toadvise 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 toprovide 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, informedconsent, instructions for use, and case report forms.

Job Requirements

REQUIRED QUALIFICATIONS

Bachelor's degree or 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 devicesubmissions.

 

* Direct experience working and collaborating with Regulatory Authorities.

 

* Ability to work overtime is required.

 

PREFERRED QUALIFICATIONS

Knowledge of FDA medical device regulations and guidance, Medical Device Regulation (EU) 2017/745, ISO 13485 QualitySystem 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.

 

* Good knowledge of product and process verification andvalidation, and risk management.

 

*  Ability to think critically, using logic and reasoning to identify the strengths and weaknesses of alternative solutions,conclusions or approaches to problems.

 

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

 

* Excellent writing and English grammar skills. 

 

* Proven ability to lead projects/work on assignments that are complex and sensitive in nature where independent action and initiative are required in resolving problems and developing recommendations.

 

 

* This position is eligible for a sign-on bonus.

 

* Relocation benefits may be available for this position.

Veran® has been empowering earlier cancer diagnosis since 2005. Our mission is to save lives by helping doctors diagnose cancer earlier and provide precision guidance to deliver potentially lifesaving therapy. Olympus Veran Technologies is a leading provider of advanced medical devices specializes in interventional pulmonology.

 

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.

 

We also embrace diversity and inclusion. 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.

 

For more information, visit medical.olympusamerica.com.

 

True To You. True To Society. True To LIFE.


Nearest Major Market: St Louis

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