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Sr. Regulatory Affairs Specialist

Eliassen Group

This is a Full-time position in Boulder, CO posted March 30, 2021.

Job DescriptionEG Life Sciences has a client in Boulder, CO looking for a Regulatory Affairs Specialist for a full-time, direct hire role. This client is a worldwide leader in the development and manufacturing of ground breaking and life changing medical devices. If you are a Regulatory Affairs Specialist who is interested in playing a part in improving the lives of millions of people around the world, this could be the opportunity for you!Our Client is looking for:Bachelor’s degree with 4+ years of experience in Regulatory Affairs in the Medical Device industry, OR Advanced degree with 2+ years of experience in Regulatory Affairs in the Medical Device industry.Experience with Class II/III medical devicesExperience with medical device global product registrations/ submissions.Experience with international regulations.Some Clinical or statistical experience would be a PLUSStrong communication and project management skillsEffective interpersonal skills to be a good team member and mentorAbility to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.Ability to effectively manage multiple projects and priorities.Experience with some of the following: FDA 510(k)s and PMAs, EU Tech Files, Heath Canada licence applications, international submissions (Japan, China, Latin America)Job ID: 348578About EG Life Sciences:Founded in 2010, EG Life Sciences is a national professional services firm that delivers flexible, scalable solutions for Medical Device, Pharmaceutical, and Biotechnology companies. We provide the resources they need to meet the unique challenges of FDA regulations and submissions. Our team is comprised of leaders who are clinical development professionals and veterans of the FDA-regulated healthcare industry with significant technical knowledge and expertise. The practice is also supported by a seasoned technical recruiting and project delivery/support team. This combination enables us to quickly deliver value-driven consulting, interim leadership, technical project management, and time and material and project-based staffing solutions.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.Don’t miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!