Regulatory Affairs Specialist II – Heart Failure (on-site)

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• 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.

Our mission is to help people with heart failure survive and thrive. At Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to monitoring and treatment.

We are recruiting for a Regulatory Affairs Specialist II to join our team on-site in Pleasanton, CA. This new team member will apply regulatory understanding to support of product and teams as well as prepare US regulatory submissions and/or registration documents. Additionally, will handle regulatory activities involved in documentation, labeling, and apply regulatory and technical knowledge to a focused area of work assignments. This Specialist understands, implements, and maintains the quality policy and ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

• Verifies with supervisory staff and executes regulatory requirements in relation to product development, submissions, product maintenance and project plans.
• Provide technical leadership and strategic input on complex issues and to business units. 
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. 
• Develop global regulatory strategies for product development and planning throughout the product lifecycle.
• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
• Implements Division Regulatory Strategy in specific product related activities.
• Basic understanding of medical device regulations.
• Obtains supervisory input for interpretation leading to the solution of issues, and to product development and support.
• Analyzes the input of product changes to current product submissions.
• Lead functional groups in the development of relevant data to complete a regulatory submission. 
• Follows through on submission related activities to secure product approval.
• Shares knowledge with others in department and on teams.
• Establishes and executes against project goals and implements plans.
• Provides input to establishing group plans and implementation of those plans.
• Follows GMP guidelines and procedures.
• Writes Effectively: Prepares written information in a clear and concise fashion, appropriately designed for varying target audiences.
• Responsible for implementing and maintaining the effectiveness of the quality system.
• Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions
• For products division-wide: Advises and communicates to project, group, or venture regarding basic regulatory strategies.
• Signs-off at team level within delegated parameters for change control.
• Directs own daily activities by utilizing team goals and division regulatory priorities.
• Provides support to Regulatory Affairs management when working towards resolution of compliance issues assuring these resolutions comply with site and division level policies and procedures and are aligned with the appropriate quality system.
• Obtains supervisory regulatory review on submission documents prior to submission to government agencies.

• Bachelor’s Degree or an equivalent combination of education and experience
• 5 years’ work experience

• Bachelor’s degree in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, engineering, etc.
• 5+ years’ experience in Medical Device industry·       
• 1-2 years of regulatory experience
• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies. Communicate effectively verbally and in writing. 
• Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Think analytically with good problem-solving skills.
• 510(k), PMA, or other international regulatory submission experience.
• RAPS Certification.