Clinical Affairs Specialist

Clinical Affairs Specialist - Verathon®

Verathon® is looking for a Clinical Affairs Specialist to become the newest member of our QA/RA Team located in Bothell, WA. This is a hybrid position, working 3 days a week (Monday, Tuesday and Thursday) in office.

The Clinical Affairs Specialist is responsible for developing and implementing clinical research, data collection and marketing studies for Verathon’s pipeline products. Specialized in writing, editing, and reviewing clinical/regulatory documents required to support market approvals.

Principal Responsibilities:

• Execute general medical writing, editing, and proofreading activities and systematic literature reviews for all of Verathon’s global teams and product portfolios
• Develop Clinical Evaluation Plans (CEP), Literature Search Protocols, Clinical Evaluation Reports (CER), Post-Market Clinical Follow-up (PMCF) plans, and Summary of Safety and Clinical Performance (SSCP)
• Support the creation of Periodic Safety Update Reports (PSUR) and other post-market reports in collaboration with Quality Engineering.
• Ensure documents are produced in accordance with standard operating procedures, internal and external guidelines (e.g., MDD and MDR), and company templates
• Participate in regulatory and notified body audits related to clinical evidence.
• Provide strategic direction to the research and development team with respect to clinical trials/research and data collection activities.
• Design, develop, document, and maintain policies and procedures to ensure that research execution meets Good Clinical Practice guidelines.
• May participate in the study development and start up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing, and presenting at investigator meetings, and working with management on monitoring strategy.
• Assist research and other project team members in additional responsibilities as required

Knowledge, Skills, and Abilities:

• A degree (e.g., BS, MS, RN, etc.) in a scientific, biological, or medical science discipline and/or regulatory discipline is required OR an equivalent of education and experience sufficient to successfully perform the essential functions of the job
• 5 years of experience creating Clinical Evaluation or Literature Reports for Medical Device submissions (including US, EU, Japan, and Canada)
• Expert understanding of systematic literature review (SLR) methodology and the requirements for the clinical evaluation of medical devices in accordance with the European Union Medical Devices Regulation (MDR) 2017/745/EC, MEDDEV 2.7/1 rev4 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, and IMDRF MDCE WG/N56FINAL:2019 Clinical Evaluation
• Strong understanding and comprehension of medical terminology and statistics
• Excellent level proficiency with word processing (Word), spreadsheets (Excel), presentation programs (Power Point), scientific search engines (PubMed, Google Scholar), and online journal/conference submission systems
• Solid written and verbal communication skills, analytical ability and problem-solving skills that enable you to work on international cross functional teams
• Strong ability to multitask and work effectively in a fast-paced environment with changing priorities
• Strong attention to detail and organizational skills

If you’re currently reading this and hesitating to click “Apply” because you don’t check all the boxes, we encourage you to go for it! A true passion and excitement for making an impact is just as important to us as work experience.

Salary range - $80,000 - $132,000 (Compensation will vary based on skills, experience and location. If this position is filled outside the Seattle WA metro area, this salary range will vary depending on the specific hiring location.)

Full-time non-sales employees are eligible for Verathon’s annual bonus plan based on company and individual performance.

Verathon provides a competitive benefits package including medical, dental, vision, basic life insurance, paid holidays, paid time off and a 401(k) matching plan. For more information, please visit our complete Benefits Summary at https://www.verathon.com/US-HQ-Employee-Benefits-Summary.

About Verathon:

Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company’s BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit www.verathon.com

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