Regulatory Affairs Manager - Medical Devices & Strategy

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

Job summary

Abbott in Alameda, CA is seeking a Regulatory Affairs Manager to lead regulatory strategy and submissions for global medical products. You will coordinate cross-functional teams, ensure compliance with FDA, EU MDR and other geographies, and drive regulatory planning and data presentation for registrations worldwide.

Ideal candidates have a Bachelor's degree and 4+ years in regulated industries, with proven leadership and strong written/verbal communication.

Qualifications

• Bachelor’s Degree in a related field OR an equivalent combination of education and work experience.
• Minimum 4 years’ experience in a regulated industry (e.g., medical products, nutritionals). 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Ability to effectively communicate verbally and in writing, prepare, and negotiate both internally and externally with diverse audiences.
• Domestic and international regulatory guidelines, policies and regulations.
• Lead functional groups in the development of relevant data to complete a regulatory submission.

Responsibilities

• Leads regulatory strategies, approval schedules and submission standards to achieve departmental objectives.
• Develops regulatory strategies and monitors compliance with FDA, ISO, EN standards and other regulatory requirements.
• Leads the RA process for review and analysis of labeling, advertising and promotional materials with Marketing teams.

Skills

Regulatory knowledge

Communication

Leadership

Regulatory submissions

Education

Bachelor's degree or equivalent

Job description

Abbott in Alameda, CA is seeking a Regulatory Affairs Manager to lead regulatory strategy and submissions for global medical products. You will coordinate cross-functional teams, ensure compliance with FDA, EU MDR and other geographies, and drive regulatory planning and data presentation for registrations worldwide.

Ideal candidates have a Bachelor's degree and 4+ years in regulated industries, with proven leadership and strong written/verbal communication.