Regulatory Specialist Sr

Abbott; Alameda (CA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical plan

Dental plan

Vision plan

Health savings account

Flexible spending accounts

Life insurance

Short-term disability

Long-term disability

Critical illness insurance

Hospital coverage

Accident insurance

MetLife benefits

401(k)

Job summary

Abbott is seeking a Senior Regulatory Specialist for a 6-month, 100% onsite role in Alameda, CA. The position requires a minimum of 7 years in Medical Device Regulatory Affairs and involves regulatory strategy, submissions, and cross-functional collaboration.

You will lead regulatory change assessments, advise on manufacturing changes and labeling, and ensure timely approvals for new and marketed devices, working with development and marketing teams to maintain compliance and product lifecycle

Qualifications

• 7 years of experience in Medical Device Regulatory Affairs.
• Experience with US regulatory submissions and approvals.

Responsibilities

• Lead regulatory change assessments.
• Work on US medical device submissions.
• Participate in continuous improvement activities, product planning and implementation, regulatory strategy, risk management, policy and intelligence.
• Ensure timely approvals for new medical devices and continued approvals of marketed products.
• Serve as regulatory representative to cross-functional teams.
• Advise development and/or marketing teams on manufacturing changes, line extensions, labeling, applicable regulations and interpretations.

Skills

Regulatory change assessments

US medical device submissions

Regulatory strategy

Risk management

Job description

Title: Regulatory Specialist Sr

Location: Alameda, CA

Duration: 6 Month's

100% Onsite

Experience Required

• Years Experience: Must have 7 years of experiences in Medical Device Regulatory Affairs

Key Skills & Responsibilities

• Considered as highly experienced with regulatory change assessments.
• Working knowledge in US Medical Device Submissions.
• Participates in some of the following: continuous improvement activities, product plan development and implementation, regulatory strategy, risk management, regulatory policy and intelligence.
• Ensures timely approval of new medical devices and continued approval of marketed products.
• Serves as regulatory representative to cross-functional teams.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labelling, appropriate regulations and interpretations.

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.