Job ResponsibilitiesGeneral Position SummaryThe Device CMC manager will support strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation for device part of the combination device. This role also provides regulatory support and guidance to various cross functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into development and commercial programs.Required Education Level & ExperienceBachelor's degree, with a preference hanical Engineering, Biology, Chemistry, Pharmacy, Regulatory Affairs, or another related life-science fieldTypically requires 4 years of experience rmaceutical industry or related field, or the equivalent combination of education and experienceExperience supporting regulatory submissions/filings for combination products, including autoinjectors, pre-filled pens, and/or pre-filled syringesExperience supporting Human Factors studies for devices and combination productsPreferred experience with infusion systems/devices for drugs/cell therapiesRequired Knowledge/SkillsStrong interpersonal skills to exchange complex information with others and to guide othersKnowledge of combination product and device regulatory requirements (FDA, EU MDR, GSPRs)Proficiency in regulatory (FDA, Notified Body, MDCG, EMA, ISO, etc.) guidelinesStrong problem-solving skillsAbility to collaborate and communicate ar, complete, timely and consistent mannerStrong sense of planning and prioritization, and the ability to work with all levels of managementSound knowledge of Design Controls, cGMP, FDA, EMA, ISO Standards (ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, ISO 11040, etc.)Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.[http://www.syneoshealth.com](http://www.syneoshealth.com)Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained hereluding the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
about 19 hours ago