Regulatory Affairs Specialist II

Abbott • Pleasanton, CA

95d • $79,500 - $138,700

About The Position

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, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. We are recruiting for a Regulatory Affairs Specialist II to join our team in the Pleasanton, CA location. In this role, you will provide support for the regulatory department to ensure efficient and compliant business processes and environment. You will play a consultative role by partnering across business functions assisting in identifying data needed, obtaining required documentation, and ensuring that submissions are effectively presented for the registration of products worldwide.

Requirements

• Bachelors Degree (± 16 years), in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred OR an equivalent combination of education and work experience.
• Master's Degree (± 18 years), Preferred.
• Minimum 2 years in a regulated industry (e.g., medical products, nutritionals).
• Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
• Regulatory agency structure, processes and key personnel knowledge.
• Principles and requirements of applicable product laws.
• Submission/registration types and requirements knowledge.
• GxPs (GCPs, GLPs, GMPs) knowledge.
• Principles and requirements of promotion, advertising and labeling.
• Domestic and international regulatory guidelines, policies and regulations knowledge.
• Ethical guidelines of the regulatory profession, clinical research and regulatory process.
• Strong attention to detail.
• Manage projects and create project plans and timelines.
• Think analytically and critically.
• Organize and track complex information.

Nice To Haves

• Bachelor’s degree in a technical discipline.
• 3+ years of related regulatory submission experience from a medical device and/or pharmaceutical industry.
• Familiar with relevant US/ EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
• Proficient with MS Office suite (Word, Excel, Outlook).
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Advanced level degree.
• Previous experience working in a highly matrixed and geographically diverse business environment.

Responsibilities

• Authors, coordinates, compiles and submits international regulatory submissions, including filing and/or creation of Technical Documentation, Premarket Notifications, Supplements, Change Notifications, and other product registrations.
• Prepares robust regulatory applications to achieve departmental and organizational objectives.
• Represents RA on cross-functional product development and manufacturing support teams.
• Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail.
• Maintains ongoing surveillance and analysis of all pertinent international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.
• Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• Interfaces directly with regulatory agencies as needed.
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
• Communicates with and maintain productive, constructive relationships with external customers as required – regulatory authorities and notified-bodies.
• Supports Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Benefits

• Career development with an international company.
• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit.
• Training and career development, with onboarding programs for new employees and tuition assistance.
• Financial security through competitive compensation, incentives and retirement plans.
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs.
• Paid time off.
• 401(k) retirement savings with a generous company match.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees