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

Abbott Laboratories • Santa Clara, CA

11d • $81,500 - $141,300 • Onsite

About The Position

The Regulatory Affairs Specialist II is an individual contributor in Abbott’s Structural Heart division, working on-site in Santa Clara, California. The position performs specialized regulatory assignments, analyses, evaluations, and preparation and submission of documentation for regulatory approval, ensuring that products and procedures comply with regulatory agency requirements. The specialist supports regulatory activities for clinical trial operations and market entry of 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 as a team member and an individual contributor in a fast-paced, changing environment, and to engage or manage others to accomplish projects.
• Strong problem-solving skills and ability to think strategically and see the big picture.
• Adaptability and ability to switch priorities and complete tasks.
• Strong verbal and written communication skills, including the ability to communicate effectively at multiple organizational levels.
• Strong organizational, follow-up, and attention-to-detail skills.
• 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 FDA and/or international regulatory agencies to support departmental and organizational objectives.
• Create, review, and approve engineering changes.
• Review device labeling and provide input.
• Serve as a core team member by reviewing and analyzing applicable regulatory guidelines and project regulatory assessments.
• Review and evaluate communications to ensure they include necessary detail and comply with FDA and other worldwide regulatory standards.
• Maintain current domestic and international medical device regulations and submission requirements in regulatory databases and file systems, and distribute information about new or modified requirements to appropriate personnel.
• Interface directly with the FDA and other regulatory agencies as needed.
• Support product release by creating GTS licenses or reviewing and approving product-release requests.
• Review protocols and reports in support of regulatory submissions.
• Support business segment initiatives and requirements related to Quality Management Systems, Environmental Management Systems, and other regulatory obligations.
• Comply with applicable U.S. FDA and international regulations, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with employees, customers, contractors, and vendors.

Benefits

• Employees can 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.

What This Job Offers

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