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Director, Regulatory Affairs

Req ID:  309

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 Director of Regulatory Affairs maintains responsibility for directing all regulatory affairs activities for Core Markets for Olympus Surgical Technologies of America (OSTA).  The Director develops, and implements global regulatory submission strategies for the earliest possible product approvals globally.  In addition the Director of Regulatory Affairs ensures the timely creation, preparation, and achievement of organized and scientifically valid regulatory submissions. This role supports the Vice President of Regulatory Affairs to plan and direct Core Regulatory Affairs Team activities including but limited to: analysis of strategic requirements and resource allocation to support of new product development teams.  The position requires strategic partnership with Olympus PDP team management and businesses leaders for introduction of Gyrus ACMI devices to the respective markets. This position also requires interaction with the respective Core Market regulatory agencies.

Job Duties

In a typical day, you will:

* Leads the overall strategy development, implementation, and coordination of regulatory affairs activities for Core Markets for Olympus Surgical Technologies of America (OSTA). 

 

* Assess regulatory pathways, and oversees the development of global regulatory strategic plans and regulatory submissions (Q-Subs, 510(K), IDE, PMA, TDF, Dossier) required to obtain registration for new OSTA products under development and throughout the product’s life cycle.

 

* Interface with International Regulatory Affairs Team to ensure global planning considerations are included in regulatory strategy development. Oversee and facilitate communication of these strategies to product teams responsible for developing new products.

 

* Create, prepare, and submit organized and scientifically valid regulatory submissions in the US (Q-Subs, 510(k) IDE, PMA, and applicable supplements and annual reports), and assist with OUS (Health Authorities, and Notified Bodies).

 

* Where designated responsible for development coordination preparation and maintenance of medical device submissions for Canadian Class 2, 3 or 4 Device License submissions.

 

* Maintain responsibility for review and approval of product labelling (including IFU) and other ancillary labelling-related matters. Facilitate team interaction with Upstream Marketing R&D and Operations in developing labelling materials.

 

* Manage and organize the Regulatory Affairs department ensuring that departmental objectives are implemented in line with the overall Q&R / OSTA Corporate goals, and within Regulatory Affairs department FY budget.

 

* Provides guidance to Regulatory Affairs staff who participate on project teams, and provide regulatory advice and direction to ensure complete and scientifically sound product submissions.

 

* Provide guidance and regulatory input to various functional groups within the company to ensure optimal development of market access strategies.

 

* Assist OSTA RA management by liaising with other Olympus (MBC) groups to provide/ share US regulatory expertise in developing project regulatory strategy and 510(k) submission support.

 

* Maintain responsibility for the development and maintenance of regulatory procedures to assure consistent efficient and compliant regulatory processes.

 

* Perform other responsibilities as requested may be assigned.

Job Requirements

REQUIRED QUALIFICATIONS:

 

* Bachelor’s degree in science, engineering or related field required.

 

* Minimum of 10 years progressively responsible US and international regulatory affairs experience in a medical device industry required; 7 Year(s) experience with Master’s Degree.  

 

* Minimum of 7 years of people-management experience.

 

* Sophisticated knowledge of and experience with FDA medical device regulations and guidance, Medical Device Directive / Medical Device Regulation and guidance, Good Clinical Practices guidance, ISO 13485 Quality System standards, and other applicable US and international regulations, guidance’s, and standards required.

 

* Successful experience with the origination 510(k), IDE, and/or PMA submissions also required.

 

PREFERRED QUALIFICATIONS:

 

* Advanced degree optimal.

 

* Create strong, effective working relationships with the FDA

 

* Communicate regulatory requirements and issues effectively within the Company, and with outside agencies and customers.

 

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

 

* A proven record of consistently following through on commitments. Maintains and communicates realistic schedules and meets or beats deadlines.

 

* Works precisely according to procedures, rules and regulations, has a passion for continuous improvement and quality.

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 || 

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