Regulatory Affairs Associate

Abbott; Alameda (CA); On-site; USD 70,000 - 110,000; Full time

Job summary

A global healthcare leader seeks a Regulatory Affairs Associate for a 6-month onsite role in Alameda, CA. The ideal candidate should possess strong regulatory knowledge and analytical skills, able to assess international regulations' impacts on business operations. This position requires collaboration with various teams to ensure compliance and navigate complex regulatory landscapes.

Benefits

Medical and Prescription Drug Plans

Vision Plan

401(k)

Qualifications

• 24+ years of hands-on experience in regulatory review and assessment.
• Experience in the Medical Device or In Vitro Diagnostics (IVD) sector preferred.

Responsibilities

• Review and assess regulatory requirements from various countries.
• Interpret regulations and identify potential compliance risks.
• Collaborate with cross-functional teams to assess regulatory impact.

Skills

Analytical skills

Regulatory knowledge

Critical thinking

Education

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Electronics

Bachelor's degree in Computer Science

Bachelor's degree in a related technical field

Job description

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Position Overview

We are seeking a highly detail-oriented

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 : 24+ 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 : Bachelors degree in Biomedical Engineering, Mechanical Engineering, Electronics, Computer Science, or a related technical field.

Top 3 Skills Required

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

Consultants Eligible Benefits Upon Waiting Period

• Medical and Prescription Drug Plans
• 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.

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Contract

Job function

Job function

Legal

Hospitals and Health Care

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