Clinical Affairs Specialist III

This is a fully remote position, open to applicants in United States.

📋 Description

• Comply with safety, environmental, security, and quality standards

• Participate in global clinical strategies for product submissions

• Act as a representative for the Clinical Affairs function within product development teams

• Ensure the integrity of clinical data to meet the requirements of the regulatory functional group

• Prepare both interim and final reports

• Provide market-specific clinical training

• Engage with and guarantee the training of investigators and clinical affairs personnel

• Assist in the monitoring of all clinical trials

• Collaborate with regulatory agencies for approvals and inquiries

• Aid in the development of Integer technology, encompassing scope, budget, and timeline

⛳️ Requirements

• Bachelor's degree in Science, Engineering, Health Science, Nursing, or a related discipline

• A minimum of 3 years of relevant professional experience; or 5-7 years if a degree is not required

• Background in the medical device or pharmaceutical sector

• Familiarity with US and international medical device regulatory submissions and approvals

• Understanding of implantable devices or other high-risk device categories

• Qualifications in accordance with MEDDEV 2.7.1 (rev 4)

• Proficient in research methodologies, information management, literature reviews, and technical writing

• Knowledge of various medical device regulations

• Experience collaborating with the medical community, including physicians

• Familiarity with feasibility, pivotal, and post-market clinical trials

• Proficient in ERP systems (Oracle, Reliance, etc.), Minitab, and Excel

🏝️ Benefits

• Health insurance

• Dental insurance

• Vision insurance

• Disability insurance

• Life insurance

• Adoption benefits

• Parental leave after one year

• 401(k) plan with company matching contributions

• 80 hours of company-designated holidays each year

• Annual allocation of paid time off