Regulatory Affairs Specialist II – Medical Devices

Cook Vandergrift in; Vandergrift (Westmoreland County); Vor Ort; USD 85.000 - 120.000; Vollzeit

Zusammenfassung

Cook Vandergrift in Vandergrift, PA, is seeking a Regulatory Affairs Specialist II (Finance) to plan and prepare submissions for regulatory approvals of medical devices. You will develop regulatory strategies and act as liaison between the Cook manufacturer and the local office or distributor.

The role requires a Bachelor's degree in a technical field, knowledge of ISO 13485, MDR 2017/745, and FDA 21 CFR Part 820, plus at least three years in the medical device industry.

Qualifikationen

• Bachelor's degree in relevant technical or scientific discipline.
• Knowledge of medical device quality standards and regulatory requirements.
• 3 years of experience in the medical device industry.
• Proficient in reading, writing and speaking English.

Aufgaben

• Maintain knowledge of ISO 13485, MDR 2017/745, FDA 21 CFR Part 820 and others as required.
• Serve as liaison on regulatory issues between the Cook manufacturer and Local Office/Distributor and Notified Body.
• Prepare regulatory submissions for new products, product changes, and re-registrations as required for specific regions.
• Create, organize, and maintain technical documentation.
• Maintain registration information and obtain re-registration approvals in advance of license expirations to ensure product availability.
• Provide support to currently marketed products including input on change requests.
• Support post market regulatory activities such as PSURs and PMCF plans.
• Maintain and organize regulatory records to demonstrate compliance.

Kenntnisse

English proficiency

Communication skills

Project management

Attention to detail

Ausbildung

Bachelor's degree

Jobbeschreibung

Cook Vandergrift in Vandergrift, PA, is seeking a Regulatory Affairs Specialist II (Finance) to plan and prepare submissions for regulatory approvals of medical devices. You will develop regulatory strategies and act as liaison between the Cook manufacturer and the local office or distributor.

The role requires a Bachelor's degree in a technical field, knowledge of ISO 13485, MDR 2017/745, and FDA 21 CFR Part 820, plus at least three years in the medical device industry.