Global Regulatory Affairs Specialist II — Medical Devices

Regulatory Jobs; Vandergrift (Westmoreland County); Vor Ort; USD 70.000 - 90.000; Vollzeit

Zusammenfassung

Regulatory Jobs seeks a Regulatory Affairs Specialist II to coordinate regulatory submissions for medical devices across global markets and to develop regulatory strategies, maintaining approvals with the manufacturing team and local regulatory offices.

The role requires up-to-date knowledge of ISO 13485, MDR 2017/745, FDA 21 CFR Part 820, and related regulations, as well as preparing change requests and supporting post-market activities with excellent documentation practices.

Qualifikationen

• 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.
• Proficient reading, writing and speaking English.

Aufgaben

• Coordinate regulatory submissions for new products and product changes.
• Maintain registrations and licenses with expiration tracking.
• Create, organize, and maintain regulatory documentation.
• Support post-market regulatory activities (PSURs, PMCF plans).
• Interact with internal teams and external regulatory bodies as needed.

Kenntnisse

Regulatory submissions

Global compliance

Communication

Ausbildung

Bachelor's degree in technical or scientific discipline

Tools

Microsoft Office

Jobbeschreibung

Regulatory Jobs seeks a Regulatory Affairs Specialist II to coordinate regulatory submissions for medical devices across global markets and to develop regulatory strategies, maintaining approvals with the manufacturing team and local regulatory offices.

The role requires up-to-date knowledge of ISO 13485, MDR 2017/745, FDA 21 CFR Part 820, and related regulations, as well as preparing change requests and supporting post-market activities with excellent documentation practices.