Regulatory Affairs Specialist II

Abbott • Temecula, CA

6d • Onsite

About The Position

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott 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. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.

Requirements

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

Nice To Haves

• 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.

Responsibilities

• Verifies with supervisory staff and executes regulatory requirements in relation to product development, submissions, product maintenance, and project plans.
• Implements Division Regulatory Strategy in specific product related activities.
• Analyzes the input of cumulative product changes to current product submissions.
• Shares knowledge with others in department and on teams.
• 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.
• Advises and communicates to project, group, or venture regarding basic regulatory strategies.
• Signs-off at team level within delegated parameters for change control.
• Release authority for labeling/sales/promotional materials.
• Official correspondence with outside regulatory agencies are guided by supervisory staff.
• Conducts basic negotiations on routine product related issues with government agencies.
• Follows through on submission related activities to secure product approval.
• 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.

Benefits

• 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.

What This Job Offers

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