Regulatory, Quality & Clinical Affairs Specialist
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Buffalo Grove, IL 60089
The Regulatory, Quality & Clinical Affairs Specialist will assist in the compliance of LMS with applicable governmental regulatory policies and procedures as well as applicable corporate and divisional policies and procedures. You will be expected to maintain current knoweldge of FDA, Health Canada, and European regulations, legislation, best practices, and guidelines related to RA/QA.
Assist in the planning, coordination, control, and continuous improvement of key components of the Quality Management System (QMS).
Ensure compliance to ISO standards, and other regulations as they pertain to the QMS, and operational processes in the conduct of study trials.
Responsible for developing and implementing quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications.
3-5 years’ experience in a regulated industry (Medical Device/Pharma company).
Regulatory Affairs background area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
High attention to details and accuracy and strong organizational and communication skills.
Bachelor’s Degree (or equivalent); Bachelor’s Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.