Regulatory Affairs Manager

Abbott Overview

Abbott is a global healthcare leader dedicated to enhancing lives across all stages of life. Our diverse portfolio of life-changing technologies encompasses diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 colleagues worldwide, we serve individuals in over 160 countries.

Medical Device Technologies

Abbott’s medical device technologies prioritize speed, efficacy, and minimally invasive procedures. From glucose monitoring systems to innovative therapies for heart disease and solutions for chronic pain and movement disorders, our technologies aim to improve lives. Each day, our innovations support over 10,000 individuals with healthier hearts, enhance quality of life for those with chronic pain, and liberate 500,000 diabetes patients from routine fingersticks.

Neuromodulation Business

Abbott’s Neuromodulation business specializes in implantable devices integrated with mobile technology to aid individuals with chronic pain and movement disorders. Our solutions include the Proclaim™ XR SCS System, leading the spinal cord stimulator market, and the Proclaim™ DRG Neurostimulator, the sole FDA-approved DRG therapy. Additionally, Abbott RFA is a market leader in radiofrequency ablation therapy, offering non-opioid alternatives for pain management.

Regulatory Affairs Manager Opportunity

Responsibilities:

• Develop global regulatory strategies for new and modified medical devices.
• Prepare robust regulatory applications to achieve organizational objectives.
• Provide leadership and guidance to cross-functional teams.
• Review device labeling and marketing materials for compliance.
• Interact independently with regulatory authorities.
• Collaborate with stakeholders to address regulatory issues.
• Stay abreast of proposed regulations and communicate requirements.

Requirements:

• Bachelor’s Degree or equivalent.
• 8+ years technical experience.
• 6+ years medical device regulatory experience.
• Strong leadership and communication skills.
• Ability to work effectively in a matrixed environment.
• Familiarity with US and global medical device regulations.
• Preferred: Technical degree, experience with regulatory submissions, and audit support.

Employee Benefits

Abbott offers a comprehensive benefits package including:

• Training and career development opportunities.
• Competitive compensation and retirement plans.
• Health and well-being programs.
• Paid time off and 401(k) matching.
• Financial stability and community involvement.

For more information on our benefits, visit Abbott Benefits.

Join Abbott for diverse career opportunities and a supportive environment. Abbott is an Equal Opportunity Employer committed to fostering employee diversity.

Connect with us at Abbott, Facebook, and Twitter (@AbbottNews and @AbbottGlobal).

Base pay for this position ranges from $95,000.00 to $190,000.00, with variations in specific locations.

Learn more here