Regulatory Affairs Associate

Abbott; Santa Clara (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical & Prescription Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Life Insurance

Short/Long Disability

Critical Illness Coverage

401(k)

Job summary

Abbott in Santa Clara, CA seeks a Regulatory Affairs Associate for a 12-month onsite assignment. You will support regulatory documentation and labeling development to ensure compliance with medical device regulations.

The role requires a bachelor’s degree in regulatory affairs or a related field and at least four years in a regulated environment, with strong communication, organization, SAP MD proficiency, attention to detail and time management.

Qualifications

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or related field.
• Minimum 4 years of experience in a regulated industry and related operations areas.
• Experience with policies and procedures affecting documentation.
• Proven experience in labeling design and development from a regulatory perspective.
• Strong knowledge of regulatory requirements for medical device labeling.
• Proficiency in SAP MD and other relevant software systems.
• Excellent communication and collaboration skills.
• Detail-oriented with strong organizational skills.
• Good administrative and time management skills.

Skills

Communication skills

Collaboration

Detail-oriented

Time management

Education

Bachelor's degree in Regulatory Affairs or related field

Tools

SAP MD

MS Office

Job description

Title: Regulatory Affairs Associate

Location: Santa Clara, California

Duration: 12 Months

100% Onsite

Qualifications:

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, or a related field.
• Minimum 4 years of experience in a regulated industry and experience in related operations areas such as quality control, quality engineering, document control, regulatory compliance, engineering and/or regulatory.
• Experience working with policies and procedures impacting documentation and documentation practices.
• Proven experience in labeling design and development from a regulatory perspective.
• Strong knowledge of regulatory requirements for medical device labeling.
• Proficiency in SAP MD and other relevant software systems.
• Excellent communication and collaboration skills.
• Detail-oriented with strong organizational skills.
• Good people relations, able to work independently with good administrative and time management skills. PC and Microsoft Office experience.

Preferred Qualifications:

• Experience with medical device labeling or labeling for highly regulated industry and international regulatory requirements.
• Familiarity with Adobe Acrobat Pro, SAP, and other content management systems.
• Substantial experience coordinating and executing project activities in a highly regulated industry.

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.