Global Regulatory Affairs Specialist – Medical Devices

Cook Group; Pennsylvania; On-site; USD 85,000 - 110,000; Full time

Job summary

Cook Group in Pennsylvania seeks a Regulatory Affairs Specialist II to plan and prepare regulatory submissions for new and modified medical devices, develop regulatory strategies, and act as a liaison between the Cook manufacturer and the International Local Office.

Maintain compliance with ISO 13485, MDR 2017/745, FDA 21 CFR Part 820, prepare documentation, manage registrations, and support post-market activities in a fast-paced, collaborative setting.

Qualifications

• Bachelor’s degree in a technical or scientific discipline.
• Knowledge of medical device quality standards and regulatory requirements.
• 3 years of experience in the medical device industry.
• Computer experience required with working knowledge of Microsoft Office.

Responsibilities

• Maintain an excellent understanding of global medical device regulations (ISO 13485, MDR 2017/745, FDA 21 CFR Part 820) as required.
• Serve as a liaison on regulatory issues between the Cook manufacturer and Local Office / Distributor and Notified Body.
• Prepare regulatory submissions for new products, changes, and re-registrations for the specific regions.
• Create, organize, and maintain technical documentation.
• Maintain registration information and obtain re-registration approvals to ensure product availability.
• Support post-market regulatory activities such as PMCF, PSURs, and Post Market Surveillance Plans.

Skills

Regulatory affairs

Medical device regulations

Communication

Project management

English fluency

Education

Bachelor's degree in a technical or scientific discipline

Tools

Microsoft Office

Job description

Cook Group in Pennsylvania seeks a Regulatory Affairs Specialist II to plan and prepare regulatory submissions for new and modified medical devices, develop regulatory strategies, and act as a liaison between the Cook manufacturer and the International Local Office.

Maintain compliance with ISO 13485, MDR 2017/745, FDA 21 CFR Part 820, prepare documentation, manage registrations, and support post-market activities in a fast-paced, collaborative setting.