Director, Quality Assurance and Regulatory Affairs
San Antonio, TX
Requisition Number: 304073
Employment Type: Direct Hire
Job Id : 304073
Job ID: 304073
Our healthcare client is seeking a Director of Quality Assurance and Regulatory Affairs to join their team.
What You'll Do:
- Ensure appropriate quality system review per FDA Quality System Regulations
- Manage oversight of corrective and preventative actions (CAPAs)
- Perform design reviews and other quality activities
- Ensure timeliness of internal audits and follow up on findings
- Ensure ongoing and proactive compliance strategy to include European Conformity (CE) requirements
- Ensure proper handling and maintenance of solutions in the Australia market
- Ensure compliance with HIPAA and security laws of individual countries where products are sold
- Cloud computing compliance: determine which apply and how to comply
- Establish compliance “knowledge base” that can be mined to extract compliance statistics and current regulations
- Provide guidance on strategy as it relates to regulatory compliance of products
Who You Are:
- Bachelor's degree in healthcare or related field; Master's degree in healthcare or relevant field preferred
- At least 10 years of progressive experience in regulatory compliance in the medical device industry
- Experience with global regulatory organizations, including the FDA
- Excellent communication (written and verbal), leadership, and management skills
- Strong technical skills
About Eliassen Group:
Eliassen Group provides strategic talent solutions to drive our clients’ innovation and business results. Leveraging nearly 30 years of success, our expertise in IT staffing, Agile consulting, creative services, managed services, and life sciences enables us to partner with our clients to execute their business strategy and scale effectively. Headquartered in Reading, MA and with offices from coast to coast, Eliassen Group offers local community presence, deep networks, as well as national reach. For more information, visit http://www.eliassen.com.
Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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