Senior Regulatory Affairs Engineer — Remote-Friendly

Aerolase; Village of Tarrytown (NY); Hybrid; USD 70,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation

Excellent health insurance

Separate office room with a view

Small team environment

Job summary

A medical device company in Tarrytown is seeking a qualified individual to develop and maintain documentation systems in compliance with US, EU, and Canadian regulations. Responsibilities include ensuring technical accuracy and defending documentation during audits. Required qualifications are hands-on experience with ISO standards and medical device regulations, alongside a degree in a relevant engineering field. The company offers competitive compensation, potential remote work, and a supportive team culture.

Qualifications

• Experience with medical device regulations and standards is essential.
• Proven ability to develop and maintain documentation systems.

Responsibilities

• Maintain documentation systems in compliance with legal requirements.
• Ensure documentation is technically sound and defensible during audits.

Skills

Hands-on experience with ISO/IEC standards

Attention to detail

Ability to work without use of AI

Education

Bachelor's degree in engineering or equivalent

Job description

A medical device company in Tarrytown is seeking a qualified individual to develop and maintain documentation systems in compliance with US, EU, and Canadian regulations. Responsibilities include ensuring technical accuracy and defending documentation during audits. Required qualifications are hands-on experience with ISO standards and medical device regulations, alongside a degree in a relevant engineering field. The company offers competitive compensation, potential remote work, and a supportive team culture.