Regulatory Affairs PM - Medical Devices (Hybrid)

Olympus Corporation; Center Valley (Lehigh County); Hybrid; USD 106,000 - 149,000; Full time

Benefits offered by this job

Competitive salaries, annual bonus and

401(k) with company match

Comprehensive medical, dental, vision

24/7 Employee Assistance Program

Paid Vacation and Sick Time

Paid Parental Leave and Adoption

12 Paid Holidays

On-Site Child Daycare, Café, Fitness

Job summary

Olympus Corporation is seeking a Regulatory Affairs professional to assist in obtaining approvals for medical devices in the US and international markets. The role focuses on strategy development, labeling reviews, and preparing submissions, with a strong emphasis on collaboration with FDA and other authorities.

The position supports hybrid work arrangements across Center Valley, PA, and Westborough, MA, with competitive compensation and benefits, including annual bonus eligibility and

Qualifications

• 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.

Responsibilities

• Develop regulatory strategy for novel technologies or market segments and lead product teams on new product development.
• Assist with due diligence assessments of regulatory posture, research and capabilities for business development.
• Review and approve product labeling and related labeling materials (IFU).
• Coordinate with Upstream Marketing and Regulatory Labeling Team on labeling materials.
• Maintain US submissions (Pre-Submissions, 510(k)s, PMAs, IDEs) and liaise with FDA reviewers.

Skills

Regulatory affairs

Medical device regulatory

FDA submissions

EU submissions

Labeling review

Regulatory communication

Education

BS/BA in engineering or life sciences

RAC accreditation

Job description

Olympus Corporation is seeking a Regulatory Affairs professional to assist in obtaining approvals for medical devices in the US and international markets. The role focuses on strategy development, labeling reviews, and preparing submissions, with a strong emphasis on collaboration with FDA and other authorities.

The position supports hybrid work arrangements across Center Valley, PA, and Westborough, MA, with competitive compensation and benefits, including annual bonus eligibility and