Regulatory Affairs Associate
Abbott, Santa Clara, CA, United States
Title:
Regulatory Affairs Associate Location:
Santa Clara, CA Duration:
12Months 100% Onsite Summary: We are looking for an experienced Regulatory Affairs professional to manage regulatory submissions and approvals for medical devices, including high-risk (Class III) implantable products. The candidate will be responsible for preparing and submitting regulatory documents and ensuring compliance with regulatory requirements. Key Responsibilities: Prepare and submit PMA applications, supplements, and annual reports Handle communication with regulatory authorities such as the FDA Review and approve engineering and validation reports Evaluate and approve manufacturing and design changes Ensure compliance with regulatory guidelines and standards Support cross-functional teams during product development and approval Maintain accurate regulatory documentation Requirements: Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field 5–8 years of experience in Regulatory Affairs (medical devices) Experience with PMA submissions and Class III medical devices Strong knowledge of FDA regulations and compliance requirements Good communication and documentation 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.
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Regulatory Affairs Associate Location:
Santa Clara, CA Duration:
12Months 100% Onsite Summary: We are looking for an experienced Regulatory Affairs professional to manage regulatory submissions and approvals for medical devices, including high-risk (Class III) implantable products. The candidate will be responsible for preparing and submitting regulatory documents and ensuring compliance with regulatory requirements. Key Responsibilities: Prepare and submit PMA applications, supplements, and annual reports Handle communication with regulatory authorities such as the FDA Review and approve engineering and validation reports Evaluate and approve manufacturing and design changes Ensure compliance with regulatory guidelines and standards Support cross-functional teams during product development and approval Maintain accurate regulatory documentation Requirements: Bachelor’s or Master’s degree in Life Sciences, Engineering, or related field 5–8 years of experience in Regulatory Affairs (medical devices) Experience with PMA submissions and Class III medical devices Strong knowledge of FDA regulations and compliance requirements Good communication and documentation 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.
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