Program Manager, Regulatory Affairs

Olympus America, Inc.; Pennsylvania; Hybrid; USD 106,000 - 149,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Paid vacation

Parental leave

On-site daycare

Employee Assistance Program

Wellbeing programs

Job summary

Olympus America, Inc. is seeking a Regulatory Affairs professional to assist the Manager in obtaining approvals for medical devices in the U.S. and other markets.

The role involves developing regulatory strategies, preparing submissions, and maintaining labeling and compliance documentation. Ideal candidates will have extensive MEDICAL DEVICE regulatory experience, 10+ years with BS/BA (or 7+ with MS), and proven collaboration with regulatory authorities.

Qualifications

• Regulatory affairs experience in Medical Device industry required.
• Minimum 10 years with BS/BA, or 7 years with MS preferred.
• Experience writing US and EU submissions.
• Direct collaboration with regulatory authorities.

Responsibilities

• Develop regulatory strategy for novel technologies and market segments.
• Assist with due diligence assessments of regulatory posture and capabilities.
• Review and approve product labeling and IFU-related matters.
• Develop labeling materials with Upstream Marketing and Regulatory Labeling Team.
• Prepare and maintain US medical device submissions (Pre-Submissions, 510(k)s, PMAs, IDEs) and related reports; liaise with FDA reviewers.
• Prepare Canadian Class 2–4 submissions where designated.
• Lead responses to regulatory authorities’ requests for information.
• Coordinate with International Regulatory Affairs for other markets (Japan, Far East, Australia, LATAM).
• Keep up-to-date with worldwide regulatory changes affecting products and processes.
• Advise regulatory and business management on changes and communicate initiatives to staff.
• Maintain regulatory files and tracking databases; provide reports to management.

Skills

Regulatory affairs

US submissions

EU submissions

Regulatory collaboration

Education

BS/BA in engineering or life sciences

RAC accreditation or post-graduate degree

Job description

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Working Location:Massachusetts, Westborough; 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 ofpatient 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.

Assist the Manager, Regulatory Affairs in obtaining approval to market 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 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 foradditional information.
• 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 orchanges to other OSTA staff.
• Responsible for maintenance of regulatory files and tracking databases toensure prompt and accurate access to company regulatory information and to provide reports to management concerning current, pending, and future approvals to management.

Job Qualifications

Required:

• BS/BA required, preferably in engineering or life sciences. RAC accreditation or Post-graduate degree preferred.
• 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.
• Experience in collaboration and working with the Regulatory Authorities directly is mandatory.

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

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

The anticipated base pay range for this full-time position in this location is$106,402.00-$148,963.00/ year, plus potential for annual bonus(subject toplan eligibility andother 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

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.