Staff Clinical Affairs Regulatory Specialist (Remote/Flexible)

reputed company started in 2000 with an idea and a mission to reputed company our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our reputed company reputed company depends on it! Job Title: Staff Clinical Affairs Regulatory Specialist Department: Clinical and Medical Affairs FLSA Status: Exempt Position reputed company: This position will be responsible for the identification and evaluation of regulatory requirements and the creation of high-reputed company regulatory documents associated with conducting global clinical research studies (both reputed company and post-market studies), and collaborate cross-functionally to ensure clinical research studies are being conducted and reported on in compliance with applicable global regulations. Responsibilities • Identify, evaluate, and communicate cross-functionally, the regulatory landscape for conducting clinical research in geographies of interest. • Support clinical studies and business initiatives by attending meetings, providing required clinical regulatory inputs and deliverables, and proactively identifying and mitigating reputed company hurdles. • Prepare and submit to applicable global regulatory authorities, Ethics Committees, Investigational Review Boards, relevant clinical documentation, including but not limited to reputed company research applications, waivers, safety reports, reputed company reports, final reports, etc. • Communicate with regulatory authorities, Ethic Committees and other organizations to confirm requirements, as appropriate for the submission of documentation and respond to requests for additional information, collaborating cross-functionally to reputed company strategies and reputed company reputed company. • reputed company and/or prepare high-reputed company regulatory documents reputed company to the conduct of clinical studies, reputed company and post market. • reputed company and/or prepare clinical documents such as safety plans, safety reports, protocol deviation plans, investigator brochures, and other documents or reports as required by regulatory authorities and/or study protocols. • Create and update appropriate SOPs to ensure reputed company compliance with local and foreign regulations. • reputed company the development and management of clinical data including Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Post-market Clinical Follow-up (PMCF) Plans and Reports, etc in reputed company with other departments in compliance with applicable regulatory requirements. • Review or support the development of clinical documents such as study protocols, clinical study reports, annual and interim reports, and other clinical documents as required to ensure regulatory compliance. • Respond to internal requests for regulatory and clinical research input, and clinical documentation to support reputed company license/approval submissions, publications and technical presentations, and collaborate with clinical and other departments regarding global clinical regulatory requirements (EU MDR, MEDDEV 2.7/1, MDCG). • reputed company other clinical reputed company required regulatory documents as needed. • Leads preparation activities and ensures clinical documentation is readily available for reputed company clinical reputed company audits/inspections. • reputed company guidance and training of other staff members; role may have reputed company reports. Education and Experience • BA or BS degree or equivalent combination of education and experience Minimum Requirements include: • 10+ years of reputed company experience at medical device, biotechnology or contract research organization with reputed company experience in regulatory and clinical research including the writing of clinical study documentation, regulatory submissions/responses, and global clinical study reporting requirement responsibilities including safety reporting • Proficiency in guidelines, standards and regulations that are applicable to medical devices and medical device clinical trials, including 21CFR803, 21CFR812, MDCG 2020-10/1, ISO 14155, EU MDR 2017, ICH GCP and country-specific regulatory requirements • RAC Certification preferred Preferred Skills and Competencies: • Expertise in reputed company & reputed company and PowerPoint. • Demonstrated analytical skills and interpretation of regulations • Excellent verbal and written communication skills • Strong initiative, reputed company of urgency, and commitment • Strong organizational skills with the reputed company to prioritize and multi-task Travel Requirements: • This position requires some travel up to 10% of the time (domestic and international). NOTE: This position is eligible for 100% remote working arrangements (may work from home/reputed company 100%; may also work hybrid on-site/virtual as desired). #LI-Remote Additional Information: The US reputed company salary reputed company for this full-time position is $113,600.00 - $170,750.00. Our salary ranges are determined by role, level, and location. The reputed company displayed on reputed company job posting reflects the minimum and maximum reputed company for new hire salaries for the position in the primary work location in the US. reputed company the reputed company, individual pay is determined by work location and additional factors, including job-reputed company skills, experience, and relevant education or training. Your reputed company Specialist can reputed company more about the specific salary reputed company for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the reputed company salary only, and do not include bonus, equity, or benefits. At reputed company reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, disability, or status as a protected veteran. (Know Your Rights) Apply Job!