Regulatory QA Engineer - Medical Devices (Onsite NJ/NY)

ARCH; Emerson (NJ); In loco; USD 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A leading medical device company is seeking a Quality, Operations, and Regulatory specialist in Emerson, NJ. The ideal candidate must have ISO 13485 certification, extensive experience in the medical device industry, and strong organizational skills. This full-time onsite role requires coordination of regulatory submissions, conducting audits, and providing strategic regulatory guidance. Suitable candidates should have a minimum of 4 years relevant experience and be located in NJ/NY. Applicants must be eligible to work in the U.S. without visa sponsorship.

Competenze

• ISO 13485 Certificate and/or strong knowledge.
• Minimum 4 years relevant work experience required.
• Experience with Export/Import preferred.

Mansioni

• Collect documentation for regulatory submissions.
• Create and maintain regulatory submission timelines.
• Provide regulatory advice to project teams.
• Develop recommendations on regulations.
• Conduct onsite audits and host regulatory agency audits.

Conoscenze

ISO 13485 knowledge

Audit Experience

Strong organizational skills

Ability to follow instructions

Communication skills

Teamwork

Independent work

Detail-oriented

Formazione

Bachelor's degree or associate degree

Strumenti

Microsoft Office applications

Descrizione del lavoro

A leading medical device company is seeking a Quality, Operations, and Regulatory specialist in Emerson, NJ. The ideal candidate must have ISO 13485 certification, extensive experience in the medical device industry, and strong organizational skills. This full-time onsite role requires coordination of regulatory submissions, conducting audits, and providing strategic regulatory guidance. Suitable candidates should have a minimum of 4 years relevant experience and be located in NJ/NY. Applicants must be eligible to work in the U.S. without visa sponsorship.