Head of Regulatory Affairs and Quality Assurance
Job Posting for Head of Regulatory Affairs and Quality Assurance at Genabio Diagnostics Inc.
Position Overview:
The employee works with the management team to
- Oversee quality and legislative requirements of all products and services
- Work with contractors and regulatory agencies for product approval and life cycle management
- Manage regulatory and technical team
Required Education, Skills and Experience:
- Minimum of a bachelor’s degree in a life scientific field such as Biochemistry, Biotechnology, Pharmacy, Medicinal chemistry, or Biomedical science
- Minimum of 5 years of experience in a similar role
- Excellent verbal and written communication skills
- Strong problem-solving skills
- Highly developed attention to detail
- Strong project management skills
- Proficiency in Chinese
Essential Functions/Responsibilities
Regulatory Affairs:
- Ensuring products in compliance with 510K regulations set by the Regulatory Agency
- Composing product, scientific and legal documents
- Working with others in the company on various products for technical and regulatory related matters
- Planning, undertaking and overseeing 510K clinical trials and FDA regulatory inspections
- Keeping up to date with changes in regulatory legislation and guidelines
- Obtaining marketing permission
- Liaising and negotiating with regulatory authorities
- Providing advice about regulations to manufacturers/scientists
- Ensuring that quality standards are met, and submissions meet strict deadlines
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Experience level:
- 5 years
Ability to Relocate:
- Bedford, MA 01730: Relocate before starting work (Required)
Work Location: In person
Salary.com Estimation for Head of Regulatory Affairs and Quality Assurance in Bedford, MA
$167,777 to $257,223
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Job openings at Genabio Diagnostics Inc.
Genabio Diagnostics Inc.
Bedford, MA
Full Time
Genabio Diagnostics Inc.
Bedford, MA
Full Time
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