Senior Regulatory Affairs Specialist

Responsibilities

• Lead the preparation and submission of robust regulatory applications to achieve organizational objectives
• Act as a regulatory representative on core product development teams, communicating requirements and impacts
• Provide expertise on complex worldwide strategies in collaboration with international regulatory affiliates
• Compile, prepare, review, and submit medical device submissions to regulatory agencies
• Interface directly with the FDA and other global regulatory bodies
• Maintain ongoing surveillance of domestic and international medical device regulations to ensure compliance
• Review device labeling for compliance with FDA submissions and applicable regulations
• Support product release processes and conduct reviews of manufacturing changes for regulatory compliance
• Provide mentoring and leadership to other members of the Regulatory team

Requirements

• Bachelor's Degree, preferably in a technical discipline such as biology, chemistry, microbiology, or medical technology
• Minimum 2 years of regulatory experience or 2 years of relevant industrial experience in quality, product development, or scientific affairs

Preferred Qualifications

• 4+ years of related regulatory submission experience in the medical device, pharmaceutical, or healthcare industry
• Advanced level degree
• Experience with Class II or Class III medical devices
• Experience with PMA supplements, 510(k) applications, and US or international medical device regulations
• Experience with risk management, design verification, or process validation
• Proficiency with MS Office suite
• Experience working in a highly matrixed and geographically diverse business environment

Benefits

• Career development opportunities within an international company
• Eligibility for free medical coverage via the Health Investment Plan (HIP) PPO plan
• Retirement savings plan with high employer contribution
• Tuition reimbursement and student debt assistance programs
• Access to FreeU education benefits

About the Company

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, including diagnostics, medical devices, nutritionals, and branded generic medicines. We serve people in more than 160 countries with a mission to advance innovative technologies that help manage and treat life's greatest health challenges.