What are the responsibilities and job description for the Quality and Regulatory Affairs Specialist, Phila., PA position at MEA - MidAtlantic Employers’ Association?
Job Description
Quality and Regulatory Affairs Specialist
Full Time, Permanent Opportunity
Philadelphia, PA
We are seeking an experienced, detail-oriented Quality and Regulatory Affairs Specialist to help ensure compliance with regulatory requirements and maintaining quality standards for our products.
This role involves close collaboration with regulatory bodies, internal teams, and other stakeholders to ensure compliance with local, national, and international regulatory requirements.
The ideal candidate should have a strong understanding of regulatory procedures and standards, such as ISO 9001, FDA regulations, etc.
In this role, you will manage product submissions, maintain regulatory documentation, and coordinate internal and external audits.
Overall Responsibilities Include
Required Experience:
Generous salary and full benefits
Keyword: ISO, FDA, National regulations, International regulations, audits
Quality and Regulatory Affairs Specialist
Full Time, Permanent Opportunity
Philadelphia, PA
We are seeking an experienced, detail-oriented Quality and Regulatory Affairs Specialist to help ensure compliance with regulatory requirements and maintaining quality standards for our products.
This role involves close collaboration with regulatory bodies, internal teams, and other stakeholders to ensure compliance with local, national, and international regulatory requirements.
The ideal candidate should have a strong understanding of regulatory procedures and standards, such as ISO 9001, FDA regulations, etc.
In this role, you will manage product submissions, maintain regulatory documentation, and coordinate internal and external audits.
Overall Responsibilities Include
- Ensure company products comply with all applicable regulations and standards.
- Develop and manage quality assurance processes and documentation.
- Coordinate with regulatory bodies for product approvals and certifications.
- Conduct internal audits and inspections to ensure compliance with regulatory standards.
- Prepare and submit regulatory documents and reports.
- Monitor changes in regulatory requirements and update processes accordingly.
- Train staff on regulatory and quality assurance requirements.
Required Experience:
- Bachelors degree in a related field such as life sciences, engineering, law, or quality management.
- Proven professional experience in quality assurance and regulatory affairs.
- In-depth knowledge of regulatory requirements and quality standards relevant to various industries such as, manufacturing, healthcare, cosmetics, food, etc.
- Proven experience with FDA, CE, and ISO regulations.
- Strong analytical and problem-solving skills
- Excellent organizational skills with the ability to manage multiple projects simultaneously
- Strong written and verbal communication skills
- Ability to interpret and apply regulatory and quality standards
Generous salary and full benefits
Keyword: ISO, FDA, National regulations, International regulations, audits
