Lighthouse Lab Services is looking for a Quality Assurance/ Regulatory Affairs specialist to join an independent reference lab located in Denver, CO. This lab is newer and the right person will feel comfortable working autonomously and have previous experience in the clinical laboratory setting.
-Leads and compiles all materials required for regulatory agency submissions, license renewal, and registrations including technical file compilation for CE and 510(k) submissions.
– Communicates with FDA and other International Competent Authorities in pre-submission and post-submission meetings and assists in the creation of all meeting and submission documentation according to relevant regulations and guidance
– Maintains and updates all current CE technical files. Communicates with European Authorized Representative to resolve any CE marking issues or discrepancies.
– Provides Regulatory Support to the Research and Development Group during the Design Control process of new products. Sits as Regulatory Affairs representative on Design Review teams and creates draft documentation and assists in protocol development that will be used in potential technical documentation for
new product submission.
– Assists in the management of clinical studies, understanding and application of data management as defined by (CLSI- Clinical Laboratory Standards Institute), including documentation of clinical study set-up, monitoring, and close-out. Ensures that trials are conducted per company internal procedures and external regulatory requirements and recommend strategies for earliest possible approvals of clinical trials applications. On site assistance maybe required to support study site.
– Keeps abreast of current global regulatory directives, standards, and communicates changes that may affect cross functional teams.
– Develops and implements regulatory strategies and processes to ensure timely global commercialization of products in compliance with applicable regulations and standards.
– Serve as the regulatory core team lead and provide active and ongoing regulatory guidance, timelines, and direction to the project teams.
– Works with customer/technical service and international partners to provide all necessary documentation for international product registrations.
– Assists in the evaluation of risk to health in potential reportable adverse events and product corrections and removals.
– Assist with FDA MDR (medical device reporting).
– Reviews and recommends changes for product labeling, manufacturing, marketing, and clinical protocols for
compliance to regulations and originally approved product claims.
– Bachelor's degree in Science or related field
– 5 years of regulatory experience, bonus if prior experience in the medical device field
– Previous experience in a start up environment
Salary and Benefits;
– 80-100k DoE
– Health, Vision, Dental
– PTO and Holidays
At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 16 years of proven success placing job seekers in positions ranging from entry level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.
It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Lighthouse Lab Services will provide reasonable accommodations for qualified individuals with disabilities.
Lighthouse Lab Services | 800-838-0602 | lighthouselabservices.com
#KW JOB ID: 15869