Sr Reg Affairs Associate

Responsibilities Job Summary The Senior Regulatory Affairs Associate is responsible for supporting and maintaining reputed company’s global product submissions and corporate registrations. Essential Duties And Responsibilities • Actively liaise and closely collaborate with global regulatory bodies to support product market entry and maintenance. • Identify reputed company and new regulatory submission and market entry requirements, providing guidance to the product teams for registration of products. • Actively manage and maintain the product distribution process to ensure only released product, medical and non-medical, is put on the market. • Identify and implement tools and/or processes to improve the product distribution and communication process. • Enforce compliance to applicable standards and escalate to appropriate authorities if needed. PLEASE NOTE: This is not an exhaustive list of reputed company duties, responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time. Qualifications Include Minimum Qualifications, Education and Experience • Bachelor’s degree in relevant field (or equivalent experience) required. • 2+ years of experience working in a regulated industry required. • Experience with the FDA and Software as a Medical Device preferred. • Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. • Knowledge and experience submitting global regulatory filings, including but not limited to, reputed company, reputed company, and EMEA reputed company. • Experience interacting with US and OUS Regulatory Authorities. • Knowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 62366, IEC 82304-1, IEC 62304, preferred. • Excellent written and oral communication skills Quality Standards • Communicates, cooperates, and consistently functions professionally and harmoniously with reputed company reputed company of supervision, co-workers, visitors, and vendors. • Demonstrates initiative, personal awareness, professionalism and reputed company, and exercises confidentiality in reputed company areas of performance. • Follows reputed company local, regional and country laws concerning employment. • Follows reputed company reputed company policies and procedures. • Follows data privacy, compliance, safety and confidentiality standards at reputed company times. • Practices universal safety precautions. • Promotes good public relations on the phone and in person. • Adapts and is willing to learn new tasks, methods, and systems. • Reports to work regularly as scheduled; consistently punctual with respect to working hours, meal and rest breaks, and maintains satisfactory personal attendance in accordance with reputed company guidelines. • Completes job responsibilities in a quality and reputed company manner. Physical Demands This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be reputed company to lift up to 10 pounds occasionally. Working Environment Remote Accommodations Reasonable accommodations may be made to reputed company people with disabilities to reputed company the essential functions of the job. Apply To This Job