Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Location: Santa Clara, CA 95054

Duration: 12 Months

Work Arrangement: Hybrid (Onsite - 4 days/ week)

Description

The Senior Regulatory Affairs Specialist (International) is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

Years Experience

• Minimum 3 years 3-4 years experience in a regulated industry (e.g., medical products, nutritionals). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Skills

• Have working knowledge in EU MDR
• Have working knowledge in Regulatory Change Assessment in
• Have working knowledge in US and EU medical device submissions
• Have experience supporting internal and external inspections
• Work cross-functionally and in a matrixed environment
• Have experience with continuous improvement activities

Education

• Bachelors Degree (± 16 years) Related field OR an equivalent combination of education and work experience
• Masters Degree (± 18 years) In Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.

Duties

• Manage and oversee the preparation of high-quality global filings for sustaining changes and new product registration. Manage rest of world (all geographies outside the US and EU) submissions.
• Strategic Planning: Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
• Assist company SME’s to interpret existing or new regulatory requirements for company products and procedures, labeling, marketing projects, testing and record keeping. May anticipate and advise on future regulatory trends and direction and recommend preemptive approaches for company regulatory.
• Proactively track global regulatory requirement changes and work with Global Strategic Intelligence (GSI) team to disseminate the information to all team members.

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.