What are the responsibilities and job description for the Regulatory Affairs Program Manager position at Olympus Corporation of the Americas?

Workplace Flexibility : Field

Please ensure you read the below overview and requirements for this employment opportunity completely.

For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling.

Every day, we live by our philosophy, True to Life, by advancing medical technologies and elevating the standard of patient care so people everywhere can fulfill their desires, dreams, and lives.

Our five Core Values empower us to achieve Our Purpose :

Patient Focus, Integrity, Innovation, Impact and Empathy.

Learn more about Life at Olympus.

Please note : All correspondence will be sent from our Olympus domain (@Olympus.com). If you receive correspondence from an entity other than @Olympus.com, it is likely not legitimate.

Job Description

Assist the Manager, Regulatory Affairs 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.

Job Qualifications

Required :

Regulatory affairs experience in the Medical Device industry is mandatory [minimum 10 years with BS / BA, or 7 years with MS 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.

BS / BA required, preferably in engineering or life sciences. RAC accreditation or Post-graduate degree preferred.

Why join Olympus?

We offer a holistic employee experience supporting personal and professional well-being through meaningful work, equitable offerings, and a connected culture.

Equitable Offerings you can count on :

Competitive salaries, annual bonus and 401(k)

with company match

Comprehensive medical, dental, vision coverage effective on start date

24 / 7 Employee Assistance Program

Free live and on-demand Wellbeing Programs

Generous Paid Vacation and Sick Time

Paid Parental Leave and Adoption Assistance

12 Paid Holidays

On-Site Child Daycare, Café, Fitness Center

Connected Culture you can embrace :

Work-life integrated culture that supports an employee centric mindset

Offers onsite, hybrid and field work environments

Paid volunteering and charitable donation / match programs

Diversity Equity & Inclusion Initiatives including Employee Resource Groups

Dedicated Training Resources and Learning & Development Programs

Paid Educational Assistance

US Only

Center Valley, PA and Westborough, MA

Are you ready to be a part of our team?

The anticipated base pay range for this full-time position working at this location is $101,523.00 - $142,132.00 / year, plus potential for annual bonus (subject to plan eligibility and other requirements). Olympus considers a variety of factors when determining actual compensation for this position including : level of experience, working location, and relevant education and certifications.

At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

Headquartered in Tokyo, Japan, Olympus employs more than 31,000 employees worldwide in nearly 40 countries and regions. Olympus Corporation of the Americas, a wholly owned subsidiary of Olympus Corporation, is headquartered in Center Valley, Pennsylvania, USA, and employs more than 5,200 employees throughout locations in North and South America. For more information, visit www.olympusamerica.com.

Olympus is dedicated to building a diverse, inclusive and authentic workplace

We recognize diversity in people, views and lifestyle choices and emphasize the importance of inclusion and mutual respect. We strive to continue to foster empathy and unity in the workplace so that our employees can fully contribute and thrive.

Let’s realize your potential, together.

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.

Applicants with Disabilities :

As a Federal Contractor, Olympus is committed to ensuring our hiring process is accessible to everyone. If you need an accommodation in order to complete the application or hiring process, please contact Olympus via email at OCAAccommodations@olympus.com. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

Posting Notes : || United States (US) || Massachusetts (US-MA) || Westborough || Quality & Regulatory Affairs (QA / RA)

J-18808-Ljbffr

Salary : $101,523 - $142,132

Apply for this job

Receive alerts for other Regulatory Affairs Program Manager job openings

Regulatory Affairs Program Manager

What are the responsibilities and job description for the Regulatory Affairs Program Manager position at Olympus Corporation of the Americas?

What is the career path for a Regulatory Affairs Program Manager?

Sign up to receive alerts about other jobs with skills like those required for the Regulatory Affairs Program Manager.

Job openings at Olympus Corporation of the Americas

Not the job you're looking for? Here are some other Regulatory Affairs Program Manager jobs in the Westborough, MA area that may be a better fit.

We don't have any other Regulatory Affairs Program Manager jobs in the Westborough, MA area right now.

AI Assistant is available now!