What are the responsibilities and job description for the Regulatory Compliance Analyst - REMOTE position at Actalent?
Equivalent Experience
Position Summary: The Regulatory Compliance Analyst will be responsible for supporting Regulatory Compliance interactions with Design Control Activities.
Essential Functions:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Position Summary: The Regulatory Compliance Analyst will be responsible for supporting Regulatory Compliance interactions with Design Control Activities.
Essential Functions:
- Actively participates in new product and reengineered product implementation teams.
- Performs quality issuance/review of documentation for product transfers.
- Reviews early stage manufacturing documentation for adherence to protocols and Good
- Completes QA Review and Release activities for new and reengineered products.
- Performs review of verification/validation protocols and reports for adherence to quality system requirements.
- Conducts audits of Design History Files
- As needed, supports compliance assessments that are required due to changes to applicable regulations.
- Supports third party inspections/audits of FDI conducted by regulatory authorities, ISO registrar and partners.
- Supports Risk Management documentation review
- Performs review of partner new material specifications and associated creation of
- Performs other duties as assigned
- B.A., B.S. in Life Science field
- Minimum of 4 years experience in an FDA regulated industry (IVD Medical Device preferable), working in a quality or regulatory compliance function.
- Working knowledge of FDA Quality System Regulations (QSR), ISO 13485/14971 standards
- Familiarity with immunoassays, antibodies/antigens, manufacturing/quality processes
- Familiarity with Design Control and Risk Management concepts
- Excellent written and oral communication skills required. Must be detail oriented and thorough
- Excellent organizational skills and the ability to balance multiple projects and priorities
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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