Regulatory Affairs Associate

Title: Regulatory Affairs Associate

Location: Alameda, CA

Duration: 6+ Months

Responsibilities:

• Will review and assess regulations from various countries for business compliance.
• Must be able to review and understand regulations with a high-level of proficiency.
• Will review, assess, and / or approve regulatory documents and initiate the process to close gaps where needed.
• Will work with other cross-functional team members in the review of regulations.
• Uses a Quality System for documenting regulatory reviews.
• Assesses the regulatory impact on cross-functional teams, R&D, Quality, Bio Compatibility, Manufacturing, Supply Chain. etc.

Key Success Factors:

• Experience in the review of Regulations & Assessing Impact to the organization/business.
• Understating about the consequences if the regulatory compliance is not met by certain dates
• Ability to Influence Cross-Functional Teams.
• Critical & Analytical Thinking.

Desired Qualifications:

•  Experience in Med Device or IVD (In Vitro Diagnostic) products.
• 2 to 4 years + in the review and assessment of regulations is a must. Understanding of EUMDR, CFR 820.30, Medical Device Design Controls, Combination devices etc.
• Bachelor’s degree in Computer Science, Mechanical Engineering, Biomedical engineering or Electronics works well for this type of work.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-