Regulatory Affairs Specialist

Abbott • Pleasanton, CA

14d • $73,900 - $116,000 • Onsite

About The Position

This Regulatory Affairs Specialist will work out of our Pleasanton, CA location in the Heart Failure Division. As an individual contributor in the function of a Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department. With limited supervision you will execute tasks and partner across business functions. As an individual contributor, the Regulatory Affairs Specialist will support product registration and regulatory activities.

Requirements

• Bachelor's Degree (± 16 years), Technical discipline preferred OR an equivalent combination of education and work experience
• No Experience, some experience with medical device industry preferred.
• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others in accomplishing projects.
• Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes, and meets deadlines in a timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

Nice To Haves

• Master’s Degree (± 18 years), In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred
• 2 years, In a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Regulatory Knowledge of: Regulatory history, guidelines, policies, standards, practices, requirements and precedents.
• Regulatory agency structure, processes and key personnel.
• Principles and requirements of applicable product laws.
• Submission/registration types and requirements.
• GxPs (GCPs, GLPs, GMPs).
• Principles and requirements of promotion, advertising and labeling. Note: This knowledge may be developed through tenure in this position.
• Communication Skills or Ability to: Communicate effectively verbally and in writing.
• Learn to write and edit technical documents.
• Work with cross-functional teams.
• Work with people from various disciplines and cultures.
• Cognitive Skills or Ability to: Pay strong attention to detail.
• Handle detailed tasks and prioritize them.
• Meet deadlines.
• Think analytically and critically.
• Review and analyze documentation.
• Research and locate information on regulatory requirements and products.
• Exercise judgment within defined procedures and practices to determine appropriate action.
• Has general knowledge of technical alternatives and gain an understanding of their impact on the systems environment.
• Apply business ethical standards.

Responsibilities

• As a professional in the Regulatory Affairs Sub-Function, possesses developing skills in product registration submission, change order management, progress reports.
• Interacts with regulatory affairs team members and other cross functional team members for regulatory submissions, product licensing and relevant documentation.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Serves as regulatory liaison throughout product lifecycle.
• Ensures timely approval of medical devices and continued approval of marketed products.
• May interface with regulatory agencies.
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
• Creates, reviews and approves engineering change orders.
• Reviews protocols and reports to support regulatory submissions.
• Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) and 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.

Benefits

• Career development with an international company where you can grow the career you dream of
• Employees can qualify for 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 - an affordable and convenient path to getting a bachelor’s degree
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level