Job Description

　　Job Title: Clinical Affairs Specialist II

　　What will you do:

　　Candidates must have a complete understanding of the IVDR requirements to ensure compliance through Clinical Evidence documentation.Author, review, and compile clinical documentation (Scientific Validity and Clinical Performance reports), along with Performance Evaluation plan, reports, and Summary of Safety and Performance reports that conform to EU IVDR and other international regulatory submissions and internal document standards, while meeting project timelines.Conduct systematic and comprehensive scientific literature reviews related to IVDs to prove state of the art.Analyze and interpret the literature data and stay updated with latest developments and trends in the field to ensure compliance of the clinical evidence.Monitor and analyze post-market data to generate post market performance reports and collaborate with cross-functional teams to identify and investigate any potential safety or performance issues.Identify opportunities to improve post-market processes and implement efficient solutions to contribute to regulatory compliance and product quality.Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.Write and maintain necessary SOPs, recall binders, and personnel training records that are required to be in compliance with GCP.Assist in the preparation of regulatory submissions to achieve departmental and organizational objectives including:-Review protocols and reports to support regulatory submissions.-Organize and assist in the review of materials for inclusion in regulatorysubmissions.Develop regulatory expertise and apply company policies and procedures to resolve routine matters. Comply with U.S. Food and Drug Administration (FDA) regulations, international regulations and other regulatory requirements, company policies, operating procedures, processes, and task assignments.Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.Maintain positive and cooperative communications and collaboration with all levels of employees.The candidate will ensure all activities are tracked and monitored and updated per a working schedule as tasks/activities are completed.

　　How will you get there:

　　BS/MS in biological sciences with minimum of 2 years of diagnostics experience, preferably with hands on experience in a medical device regulated environment/industry.Strong understanding of analytical and clinical performance testing, experience with toxicology and therapeutic drug monitoring products is a plus.Must be self-motivated, adaptable, and have a positive attitude.Proficient in MS applications (Office, Teams, Outlook).IVDR experience is a plus.

　　Compensation and Benefits

　　The salary range estimated for this position based in California is $79,200.00-$118,800.00.

　　This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

　　A choice of national medical and dental plans, and a national vision plan, including health incentive programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policyRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings planEmployees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

　　For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards