RA Specialist II

Olympus Corporation of the Americas; Westborough (MA); Hybrid; USD 91,000 - 123,000; Full time

Benefits offered by this job

Competitive salary

401(k) with match

Medical/dental/vision coverage

Paid time off

Parental leave

On-site facilities

Job summary

Olympus Corporation of the Americas is seeking a Regulatory Affairs professional to assist the Manager Regulatory Affairs in obtaining approvals to market Olympus medical devices in the markets we serve. Hybrid roles span Massachusetts, Minnesota and Pennsylvania with on-site and remote collaboration.

You will participate in global regulatory strategies, prepare US 510(k)/Pre-Submissions, and interface with EU and other international teams to support registrations.

Qualifications

• Regulatory affairs experience in the Medical Device industry is mandatory [minimum 3 years with BS/BA or 1 year with MS preferred].
• RAC accreditation a plus.

Responsibilities

• 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.
• Develop, coordinate, prepare and maintain US medical device submissions such as 510(k)s and Pre-Submissions and liaise with FDA reviewers as needed.
• Develop, coordinate, prepare and maintain medical device submissions for Canadian Class 2/3/4 Device License submissions.
• Respond to regulatory authorities' requests for additional information.
• 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.
• 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.
• Assist in the development and maintenance of regulatory procedures to assure consistent efficient and compliant regulatory processes.

Skills

Regulatory affairs

Education

BS/BA in engineering or life sciences

MS preferred

Job description

Working Location: Massachusetts, Westborough; Minnesota, Brooklyn Park; Pennsylvania, Center Valley

Workplace Flexibility: Hybrid

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: https://www.olympusamerica.com/careers .

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 Qualifications

Required:

• Regulatory affairs experience in the Medical Device industry is mandatory [minimum 3 years with BS/BA or 1 year with MS preferred].

Preferred:

• BS/BA required preferably in engineering or life sciences.

• RAC accreditation a plus.

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

• 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?

Learn more about our benefits and incentives: https://www.olympusamerica.com/careers/benefits-perks .

The anticipated base pay range for this full-time position in this location is $91,148.00 - $123,049.00 / 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 .

You Belong at Olympus

We are deeply committed to fostering a respectful, fair, and welcoming workplace for all individuals, perspectives, and lifestyles. We believe in fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish. We warmly encourage all who wish to bring their talents to Olympus to apply.

Applicants Requesting Accommodations:

Olympus is committed to the full inclusion of all qualified individuals. As part of this commitment, Olympus will ensure that persons with disabilities are provided reasonable accommodations for the hiring process. If reasonable accommodation is needed, please contact [e-mail]. If your disability impairs your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (1-888-659-6787).

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.

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