Regulatory Quality Engineer - Accelerate Device Compliance

Science Corp; Alameda (CA); On-site; USD 115,000 - 175,000; Full time

Benefits offered by this job

Competitive salary and equity

Medical, dental, vision and life insurance

Flexible vacation and company-paid holidays

Healthy meals and snacks

Paid parental and medical leave

401(k)

Job summary

A pioneering technology firm in California seeks a QARA Engineer to drive regulatory compliance for innovative medical devices. The role requires an engineering degree and at least three years of experience across pre-clinical, clinical, and manufacturing phases. Responsibilities include leading regulatory submissions, managing project timelines, and supporting quality management initiatives. A competitive salary ranging from $115,000 to $175,000, alongside equity and benefits, is offered to the successful candidate.

Qualifications

• Minimum of 3 years' experience in pre-clinical, clinical, manufacturing, and post-market of medical devices.
• Strong knowledge of medical device regulations, particularly FDA 21 CFR and EU MDR.
• Detail-oriented with strong organizational skills.

Responsibilities

• Develop and implement regulatory strategies for new products.
• Lead regulatory submissions and ensure compliance.
• Manage quality oversight of preclinical studies.

Skills

Regulatory compliance

Project management

Quality management

Strong communication

Problem solving

Education

Engineering Degree or equivalent in quality, regulatory and/or life sciences

Tools

GxP regulations

Electronic QMS

Project-management tools (e.g., Asana)

Job description

A pioneering technology firm in California seeks a QARA Engineer to drive regulatory compliance for innovative medical devices. The role requires an engineering degree and at least three years of experience across pre-clinical, clinical, and manufacturing phases. Responsibilities include leading regulatory submissions, managing project timelines, and supporting quality management initiatives. A competitive salary ranging from $115,000 to $175,000, alongside equity and benefits, is offered to the successful candidate.