Regulatory Affairs Associate

Abbott • Contract • Santa Clara, CA, US • $41 - $46 / hour • 2d ago

Our Santa Clara, California location currently has an opportunity for a Regulatory Affairs Associate.

We are seeking a highly skilled and experienced Regulatory Affairs Associate to join our team. This role is critical in ensuring compliance with all applicable regulatory requirements for Class III implantable medical devices. The ideal candidate will have a strong background in regulatory submissions, government interactions, and a proven track record of successful PMA supplement approvals.

Title: Regulatory Affairs Associate

Location: Santa Clara, California

Duration: 4 months

Responsibilities:

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and approval of manufacturing changes for Class III implantable medical devices.

Key Success Factors:

Demonstrated ability to think creatively and work independently with a high degree of latitude.
Strong problem-solving skills and attention to detail.
Ability to manage multiple projects and meet tight deadlines.
Excellent communication and collaboration skills across cross-functional teams.
Experience working in a fast-paced, highly regulated environment.
Proficiency in regulatory software and document management systems.

Qualifications:

Bachelor’s degree in a scientific or engineering discipline.
3-4 years regulatory affairs experience with medical devices.
Basic knowledge of US and EU medical device regulatory requirements.
Experience with change management and regulatory impact assessments.
Experience with technical documentation.

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.

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