Senior Clinical Research Scientist - Device Trials Leader

Regulatory Jobs; Alameda (CA); On-site; USD 114,000 - 228,000; Full time

Job summary

Abbott in Alameda, CA is seeking an experienced clinical affairs professional to organize and conduct evaluations for new products and product improvements. You will serve as the clinical resource on development teams, interacting with R&D, Regulatory Affairs, QA and Marketing to identify user needs and market segments.

The role requires deep clinical knowledge, strong documentation skills for regulatory submissions, and collaboration with biostatistics, data management and external

Qualifications

• Bachelor’s Degree in Biological Science or related field with a minimum of 9 years of related work experience. Master’s Degree is preferred.
• Works in a quality system environment and adheres to governmental regulations.
• Ability to collaborate across R&D, Regulatory Affairs, Quality Assurance and Marketing.

Responsibilities

• Provide clinical knowledge for clinical study protocol development, trial design, analysis and interpretation.
• Create high quality, scientifically sound documents for clinical research and regulatory submissions (e.g., FDA).
• Utilize PubMed and referencing software for literature review and data synthesis.
• Evaluate new product ideas by reviewing literature and summarizing information for decision making.
• Contribute to risk analysis for new or improved devices to identify patient and study risks.
• Develop clinical performance evaluation plans to assess physician acceptance and product performance.

Education

Bachelor’s Degree in Biological Science

Master’s Degree preferred

Job description

Abbott in Alameda, CA is seeking an experienced clinical affairs professional to organize and conduct evaluations for new products and product improvements. You will serve as the clinical resource on development teams, interacting with R&D, Regulatory Affairs, QA and Marketing to identify user needs and market segments.

The role requires deep clinical knowledge, strong documentation skills for regulatory submissions, and collaboration with biostatistics, data management and external