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Director, Strategic Regulatory Affairs

Abbott Laboratories

This is a Full-time position in Austin, TX posted May 16, 2021.

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, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.

Our 109,000 colleagues serve people in more than 160 countries.

Our Neuromodulation business is an area of expertise for Abbott.

This business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders.

Our Solutions include Proclaim (TM) XR SCS System, the #1 Spinal cord stimulator on the market, Proclaim (TM) DRG Neurostimulator, the only FDA approved DRG therapy and a market leader in radiofrequency ablation therapy, Abbott RFA.

These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

Our deep brain stimulation technology for progressive diseases help people manage their Parkinson’s disease and essential tremor symptoms, steering away from side effects.

Our location in Austin, TX currently has an opportunity for a Director of Strategic Regulatory Affairs.

The Director combines knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.

The individual has division level influence and is generally considered a key opinion leader and an expert resource both within Abbott and externally.

The individual may influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information.

WHAT YOU’LL DO​

Innovation & Portfolio Strategy
Drive clarity around worldwide regulatory strategy for neuromodulation digital roadmap Drive evidence generation and labeling improvements, including via real world evidence or international registries Characterize the regulatory landscape for direct competitors and adjacencies to support portfolio prioritization
Product & Geographic Expertise
Interface with authorities to shape the regulatory environment for neuromodulation technologies Drive efficiencies for regulatory approvals of platform technologies across therapies Mentor RA team members on neuromodulation submission deliverables and improve quality and consistency
EDUCATION AND EXPERIENCE YOU’LL BRING
Minimum 7-10 years experience in a regulated industry Technical / Business Knowledge of monitoring costs of projects and of human and material resources within a department.

Strong Attention to detail Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues Certifications are a plus (such as RAC from the Regulatory Affairs Professionals Society)

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