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

Abbott • Santa Clara, SC

10d • Onsite

About The Position

The Regulatory Affairs Specialist II is an individual-contributor role in Abbott’s Structural Heart division, based on-site in Santa Clara, California. The specialist performs regulatory analyses and prepares and submits documentation for regulatory approval, ensuring products and procedures comply with regulatory agency requirements. The position supports regulatory activities needed for clinical trial operations and product market entry, including work on a transcatheter heart valve replacement device.

Requirements

• Bachelor’s degree or an equivalent combination of education and work experience.
• At least 3 years of related experience, including at least 2 years of regulatory experience.
• Experience with either 510(k) applications, IDE supplements, PMA supplements, and U.S. device regulations, or EU and other international medical-device regulations and submissions.
• Ability to work both within a team and independently in a fast-paced, changing environment.
• Ability to leverage, manage, or engage others to accomplish projects.
• Strong problem-solving skills and the ability to think strategically and see the big picture.
• Adaptability and ability to change priorities while completing tasks.
• Strong verbal and written communication skills, including the ability to communicate effectively at multiple organizational levels.
• Strong organizational and follow-up skills, with attention to detail.
• Ability to multitask, prioritize, and meet deadlines in a timely manner.

Nice To Haves

• Bachelor’s degree in a science or technical discipline, such as engineering, life sciences, or mathematics.
• Master’s degree.
• Experience with regulatory activities required for clinical trials.
• Experience working in a broader enterprise or cross-division business-unit model.
• Experience working in the medical device industry.
• Regulatory Affairs Professionals Society certification.

Responsibilities

• Prepare regulatory applications for the FDA or international regulatory agencies.
• Create, review, and approve engineering changes.
• Review device labeling and provide input.
• Serve as a core team member by reviewing applicable regulatory guidelines and preparing project regulatory assessments as needed.
• Review and evaluate communications to ensure they include necessary details and meet applicable FDA and international regulatory standards.
• Maintain current domestic and international medical device regulations and submission requirements in regulatory databases and file systems, and distribute new or modified requirements to appropriate personnel.
• Potentially interface directly with the FDA and other regulatory agencies.
• Support product release by creating GTS licenses or reviewing and approving product-release requests.
• Review protocols and reports supporting regulatory submissions.
• Support business-segment initiatives and requirements involving QMS, EMS, and other regulatory obligations.
• Comply with FDA and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with employees at all levels, customers, contractors, and vendors.

Benefits

• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to a bachelor’s degree.
• Career development opportunities with an international company.

What This Job Offers

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