Global Regulatory Affairs Specialist II – Medical Devices

Cook Vandergrift; Vandergrift (Westmoreland County); On-site; USD 85,000 - 120,000; Full time

Job summary

Cook Vandergrift is seeking a Regulatory Affairs Specialist II to plan and prepare regulatory submissions for medical devices in Vandergrift, PA. You will develop regulatory strategies, obtain approvals, and liaise between the Cook manufacturer and local/ distributor offices.

The role requires knowledge of global regulations (ISO 13485, MDR, FDA), along with strong documentation and communication skills. Travel is modest and the position is full-time, based on-site in Vandergrift.

Qualifications

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

Responsibilities

• Maintain familiarity with ISO 13485, MDR 2017/745, FDA 21 CFR Part 820 and other regulations.
• Prepare regulatory submissions for new products, product changes and re-registrations.
• Create, organize, and maintain technical documentation.
• Maintain registration information and obtain re-registration approvals before license expirations.
• Support post-market regulatory activities including PMCF plans and PSURs.

Skills

Regulatory knowledge

Documentation management

Cross-functional collaboration

Attention to detail

Education

Bachelor's degree in technical or scientific field

Tools

Microsoft Office

Job description

Cook Vandergrift is seeking a Regulatory Affairs Specialist II to plan and prepare regulatory submissions for medical devices in Vandergrift, PA. You will develop regulatory strategies, obtain approvals, and liaise between the Cook manufacturer and local/ distributor offices.

The role requires knowledge of global regulations (ISO 13485, MDR, FDA), along with strong documentation and communication skills. Travel is modest and the position is full-time, based on-site in Vandergrift.