Regulatory Affairs Associate

Title: Regulatory Affairs Associate

Location: Alameda, CA

Duration: 6 Month (100% onsite)

Position Overview:

We are seeking a highly detail-oriented Regulatory Affairs Associate to join our team in Alameda, CA. This role is fully onsite and requires strong analytical skills, regulatory knowledge, and the ability to assess the impact of international regulations on business operations. The ideal candidate will have a proven ability to review and interpret complex regulatory requirements and provide actionable insights for business compliance.

Key Responsibilities:

• Review and assess regulatory requirements from various countries to ensure business compliance.
• Interpret regulations with a high level of proficiency and identify potential compliance risks and business impacts.
• Evaluate the consequences of non-compliance, particularly with respect to regulatory deadlines and critical milestones.
• Review, assess, and/or approve regulatory documentation and initiate corrective actions where compliance gaps exist.
• Collaborate with cross-functional teams including R&D, Quality, Biocompatibility, Manufacturing, and Supply Chain to determine regulatory impact.
• Utilize established Quality Systems to document regulatory reviews and ensure compliance with internal protocols.
• Support the development and implementation of strategies that address identified regulatory risks.

Must-Have Qualifications:

• Experience: 2–4+ years of hands-on experience in regulatory review and assessment.
• Regulatory Knowledge: Familiarity with key regulatory standards including:
• EUMDR (European Union Medical Device Regulation)
• CFR 820.30 (Design Controls)
• Medical Device Design Controls
• Combination Devices
• Industry Experience: Prior experience in the Medical Device or In Vitro Diagnostics (IVD) sector.
• Technical Proficiency: Strong analytical and critical thinking abilities to interpret regulatory documentation.
• Education: Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electronics, Computer Science, or a related technical field.

Top 3 Skills Required:

1. Experience in reviewing regulations and assessing their impact on business operations.
2. Ability to influence and collaborate effectively with cross-functional teams.
3. Strong critical thinking and analytical problem-solving skills.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

 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-changing breakthroughs, performing key duties to create life-changing breakthroughs.