Get new jobs for this search by email

Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system, Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidance are met, Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission, including maintaining tracker of Declarations of Conformity, confirming against local requirements, and driving to issuance. Driving quality system process improvement initiatives

Title : Regulatory Affairs Associate

Location : Santa Clara, California

Duration : 6 Month

100% Onsite

Responsibilities

Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system, Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidance are met, Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission, including maintaining tracker of Declarations of Conformity, confirming against local requirements, and driving to issuance. Driving quality system process improvement initiatives

Initiatives Include But Are Not Limited To

Establishing emerging issues in our quality system, Maintaining the quality system procedures (e.g. change management), Liaising with cross-functional partners, distribution centers, and international affiliates to obtain/align on international regulatory requirements, Troubleshooting with regulatory affiliates and Participating in RA projects.

List Of Tasks

CFG requests in the FDA database. Declarations of conformity. Review Regulatory Letters and maintain LoA / PoA tracker. Will coordinate pan-franchise requests for multiple products, schedule meetings with international requesters. Maintain tracker / SharePoint / folders with current state. Change management

Role has a potential for investigating non-conformances (CAPAs) and implementing mitigations. Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.

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. Seniority level

Seniority level Entry level Employment type

Employment type Contract Job function

Job function Legal Industries Hospitals and Health Care Referrals increase your chances of interviewing at Abbott by 2x Get notified about new Regulatory Affairs Associate jobs in

Santa Clara, CA . San Jose, CA $80,000 - $90,000 3 months ago Mountain View, CA $75,000 - $90,000 4 weeks ago Union City, CA $110,000 - $120,000 2 weeks ago Regulatory Affairs Specialist - (NMPA/CFDA)

Sunnyvale, CA $97,600 - $165,200 1 week ago Sunnyvale, CA $97,600.00 - $165,200.00 1 week ago Pleasanton, CA $115,000.00 - $125,000.00 1 week ago Sunnyvale, CA $80,900.00 - $128,800.00 2 weeks ago Senior Regulatory Affairs Specialist - Vascular (on-site)

Regulatory Affairs Specialist I - Heart Failure (on-site)

Pleasanton, CA $72,100.00 - $114,700.00 1 week ago Milpitas, CA $115,000.00 - $150,000.00 1 week ago Sr Regulatory Affairs Specialist (Remote) - Shockwave

Santa Clara, CA $89,000.00 - $165,600.00 1 day ago Regulatory Affairs Specialist - Pleasanton, CA

Pleasanton, CA $115,000.00 - $125,000.00 6 days ago Sr Regulatory Affairs Specialist (Ad/Promo) (Remote) - Shockwave

Santa Clara, CA $89,000.00 - $165,600.00 15 hours ago Senior Regulatory Affairs Specialist -Vascular (on-site)

Sr Regulatory Affairs Specialist - Shockwave Medical

Santa Clara, CA $89,000 - $165,600 15 hours ago Senior Regulatory Affairs Specialist – Vascular (on-site)

Sunnyvale, CA $80,000 - $140,000 7 months ago Regulatory Affairs Manager – Heart Failure (on-site)

Pleasanton, CA $112,000 - $224,000 2 weeks ago Senior Regulatory Affairs Specialist - Digital Health Technologies (on-site)

Regulatory Affairs Manager – Vascular (on-site)

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr