Since 1969, Inter Science Institute has been a leader in making advanced research procedures and tests accessible for clinical testing and research applications. We are seeking an experienced Regulatory Manager to join our team, responsible for preparing technical documents to support both domestic (FDA) and international regulatory submissions for our Laboratory Developed Tests (LDTs). The ideal candidate will be available to commit to 3-4 days per week onsite in Inglewood, CA and possess the following experience and skillset:
This is a part-time position (3-4 days per week onsite) + benefits
Professional Experience:
Extensive experience (5-10 years) in preparing and submitting regulatory documents to the FDA, particularly for in vitro diagnostic devices (IVDs) and LDTs.
Familiarity with the FDA’s 510(k) submission processes
Create submission templates formated/styled in line with guidelines established by FDA regulatory requirements.
Previous experience in a clinical laboratory setting, preferably in a leadership or supervisory role.
In-depth understanding of laboratory regulations and compliance requirements under CLIA (Clinical Laboratory Improvement Amendments).
Proven project management skills, including the ability to manage multiple projects simultaneously, set priorities, and meet deadlines.
Strong knowledge of Quality Management Systems (QMS) and compliance with FDA regulations, including Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).
Ability to analyze complex data, identify issues, communicate/implement solutions.
Familiarity with statistical analysis and validation of clinical tests.
Excellent written and verbal communication skills to effectively interact with regulatory agencies and cross-functional teams.
Ability to write clear and comprehensive regulatory documents.
Preferred Qualifications:
Experience with FDA submissions for IVDs:
Direct experience in the requirements and regulatory submission of IVDs
Knowledge of the latest FDA guidelines and policies related to LDTs.
Adaptability:
Ability to stay updated with evolving regulatory landscapes and quickly adapt to new requirements.
Attention to Detail:
High level of accuracy and attention to detail to ensure all regulatory submissions meet stringent requirements with minimal direction.
Education:
A degree in chemistry or a related field is desired, however, industry experience is really what we are looking for.
Additional regulatory qualifications advantageous
5-10 years relevant experience of US, European or Global registration procedures (or significant experience in IVDs)
In-depth knowledge of the Global Regulatory Affairs environment – Guidelines and legislation
Deep practical knowledge of the IVDs regulatory processes in the US and background understanding of regulatory processes in other regions
Job Types: Full-time, Part-time
Pay: $85,000.00 - $100,000.00 per year
Expected hours: 24 – 32 per week
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
- Health insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Experience level:
Schedule:
Experience:
- FDA regulations: 5 years (Preferred)
Ability to Commute:
Ability to Relocate:
- Inglewood, CA: Relocate before starting work (Required)
Work Location: In person