Manager/Director of Regulatory Affairs and Quality Assurance Cleveland HeartLab
THIS JOB HAS EXPIRED Cleveland HeartLab, Inc. is a rapidly growing specialty clinical laboratory and disease management
company focused on biomarker technologies. We are located in the Cleveland, OH Midtown Corridor
and are searching for a Manager/Director of Regulatory Affairs and Quality Assurance.
This position is responsible for:
? Developing regulatory strategies for submission of new products to US, European, and any
other applicable regulatory bodies.
? Preparing, planning, coordinating and submitting all regulatory documents to proper agencies.
? Assisting in project development activities including review of product specifications, risk
analysis, and verification and validation testing.
? Providing necessary definition, development and deployment of product quality assurance
strategy, addressing all phases of product development.
? Ensuring the company?s regulatory requirements are in compliance with the Food and Drug
Administration?s Good Manufacturing Practice requirements.
? Preparing documentation and systems for compliance with ISO and European requirements.
? Assisting in analyzing and evaluating information concerning manufacturing problems, customer
complaints, non-conformances, quality systems and product quality.
? Initiating investigations, corrective action plans, and trending of non-conformances.
? Ensuring the company is committed to and conforms to the company quality systems
procedures as documented.
The successful candidate will possess:
? 5 years or more experience in regulatory affairs/quality assurance within the IVD/medical device
industry, or equivalent.
? A strong knowledge of FDA submissions including 510k.
? RAC certification.
? Solid quality systems background and knowledge of cGMP, QA/QC principles, and compliance
systems with a broad understanding of statistics, verification and validation and other quality
? Working knowledge of EN13485 and US FDA Quality System Regulation.
? Strong technical written, verbal and interpersonal skills.
? A minimum of a BA/BS in scientific or technical field
We offer an excellent benefits package which includes medical, dental, vision, life and disability
along with a matching 401K plan.
It is the policy of Cleveland HeartLab to consider candidates without regard to race, color, religion,
gender, national origin, ancestry, genetic information, age, disability, or any other condition protected
by applicable law. We are a drug free workplace.
||Cleveland, OH |
THIS JOB HAS EXPIRED