Hybrid Regulatory Affairs Program Manager, Medical Devices

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

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.