Regulatory Affairs Associate

Job Title: Regulatory Affairs Associate

Location: Alameda, CA

Duration: 12 Months

Work Arrangement: 100% Onsite

Position Overview

We are seeking a Regulatory Affairs Associate to support the Regulatory Affairs department by ensuring efficient, compliant business processes and regulatory activities. This role will focus on reviewing labeling, advertising, and promotional materials, supporting regulatory submissions, collaborating with cross-functional teams, and ensuring compliance with domestic and international regulatory requirements.

Regulatory Review & Compliance

• Review and analyze product labeling, advertising, and promotional materials for regulatory compliance.
• Partner with Marketing teams to provide regulatory strategy and compliance guidance.
• Determine regulatory risks, identify required supporting data, and ensure claims are accurate and substantiated.
• Review promotional content prior to distribution to ensure compliance with regulatory requirements.
• Support compliance with post-market approval requirements.

Regulatory Submissions

• Assist with regulatory submissions for:

1. 510(k)
2. PMA
3. Health Canada
4. Latin America regulatory submissions

• Support New Product Introduction (NPI) and marketed product regulatory activities.

Process Improvement

• Assist in developing and reviewing Regulatory Affairs Advertising & Promotion (Ad & Promo) Standard Operating Procedures (SOPs).
• Communicate regulatory approval requirements to cross-functional teams.
• Support continuous improvement of regulatory processes and documentation.

Cross-Functional Collaboration

• Work closely with:
• Marketing
• Quality
• Research & Development
• Scientific Affairs
• Operations
• Provide regulatory guidance throughout product development and commercialization.

Education

• Bachelor's degree or an equivalent combination of education and relevant work experience.

Experience

• Minimum 2 years of experience in a regulated industry such as:
• Medical Devices
• Pharmaceuticals
• Nutrition
• Food
• Regulatory Affairs experience preferred.
• Experience in Quality Assurance, Research & Development, Scientific Affairs, Operations, or related regulated functions will also be considered.

Required Skills

• Regulatory Affairs
• Labeling review
• Advertising & promotional material review
• Regulatory compliance
• Regulatory submissions (510(k), PMA, Health Canada)
• Medical device regulations
• Technical writing and document review
• Cross-functional collaboration
• Project management
• Strong analytical and critical thinking skills
• Excellent verbal and written communication
• Attention to detail
• Regulatory risk assessment
• Documentation management
• Microsoft Word, Excel, PowerPoint, Visio, and SharePoint

Preferred Qualifications

• Bachelor's degree in:

1. Biology
2. Chemistry
3. Microbiology
4. Immunology
5. Medical Technology
6. Pharmacy
7. Pharmacology
8. Engineering
9. Regulatory Affairs
10. Other medical or scientific discipline

• 1+ year of Regulatory Affairs or Quality experience within the Medical Device industry.
• Experience reviewing:

1. Product labeling
2. Promotional materials
3. Advertising materials

• Knowledge of:

1. FDA regulations
2. Medical Device Quality Systems
3. Domestic and international regulatory requirements
4. Promotion, advertising, and labeling regulations
5. Regulatory agency processes
6. Ethical standards within Regulatory Affairs

• RAC (Regulatory Affairs Certification) 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.