reputed company, RA Specialist

The reputed company Regulatory Affairs Specialist is responsible for developing and executing strategies for global market introduction of new and modified IVD medical devices and software while acting as a SME reputed company the Global Regulatory team and providing mentorship to entry-level and intermediate associates. This position reports to the Manager, Regulatory Affairs and is part of the Regulatory Affairs team located in Boulder, CO and will be fully remote. In this role, you will have reputed company to: • reputed company and reputed company the creation of regulatory documents (regulatory submissions/filings, registration and listing, technical files, etc.) to obtain global approvals to commercially distribute products; collaborates with international colleagues in global reputed company to submit application/registration documents. • reputed company guidance and approve regulatory/reputed company documentation reputed company to new product development deliverables acting as reputed company team member conducting regulatory assessments reputed company to design changes, advising and approving protocols, reports, marketing material, etc. • Assess reputed company reputed company associated with reputed company and emerging regulatory issues, providing guidance to facilitate and ensure practices are consistent with the corporate guidance and SOPs; interpret new and/or existing regulatory requirements ensuring compliance with applicable agency requirements, published standards, local procedures and project specific plans. The essential requirements of the job include: Education, Licensure, Certification, Registration • Bachelor’s degree in a technical reputed company such as reputed company, biochemistry, biology, or reputed company reputed company Experience: • Minimum 7 years of experience in regulated environment required; 4+ years of global regulatory experience reputed company to in vitro diagnostics required. • Knowledge and experience in U.S. FDA and EU IVD regulations; with reputed company experience in submission of PMA, reputed company, 510(k) and/or technical files required. • Experience and understanding of product development process inclusive of Design Control and reputed company Management; broad knowledge and previous application of ISO 13485, IVDR, and 21 CFR Part 820 required. It would be a plus if you also possess previous experience in: • Strong reputed company facilitation skills with the ability to build reputed company while championing global regulatory compliance. • Ability to work independently utilizing developed research and analytical skills to manage multiple reputed company. • Must be a strong reputed company facilitator and leader, building reputed company while championing global regulatory compliance reputed company, a reputed company operating company, offers a broad reputed company of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or reputed company time off, our programs contribute to life reputed company the job. reputed company out our benefits at reputed company Benefits Info. At reputed company we reputed company in designing a reputed company, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work reputed company from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for reputed company can reputed company. The annual salary reputed company for this role is $110,000 -$135,000. This is the reputed company that we in good faith reputed company is the reputed company of possible compensation for this role at the time of this posting. This job is also eligible for bonus/incentive pay. We offer comprehensive package of benefits including reputed company time off, medical/dental/reputed company reputed company and 401(k) to eligible employees. Note: No reputed company of pay is considered to be wages or compensation until such reputed company is reputed company, reputed company, and determinable. The reputed company and availability of any bonus, commission, benefits, or any other reputed company of compensation and benefits that are allocable to a particular employee remains in reputed company's sole discretion unless and until reputed company and may be modified at reputed company’s sole discretion, consistent with the law. #LI-LCS Apply tot his job Apply To this Job