Abbott Manager, Regulatory Affairs in Plano, Texas
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 107,000 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 Plano, TX, currently has an opportunity for a Manager, Regulatory Affairs. This position manages the Regulatory Affairs function for the Neuromodulation Business. It is responsible for planning, creating and implementing solutions for regulatory approvals of products.
WHAT YOU’LL DO
Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Maintains a safe and professional work environment.
Develops global regulatory strategies for new and modified medical devices.
Provides Regulatory leadership to development teams, e.g., global regulatory strategies and cross functional alignment with issues of possible Regulatory ramifications and mentoring junior regulatory staff.
Acts as a liaison with other departments, e.g., Quality, R&D, Legal, Operations, Marketing and Clinical Affairs, for major initiatives.
Provides technical guidance and training to RA staff: o during strategy formulation, submission preparation and development of labeling, marketing or promotional materials and in o training on departmental policies and procedures, new FDA guidance documents, and FDA warning letters, competitor updates.
Prepares submissions for new devices and device or manufacturing changes.
Reviews product and manufacturing changes for compliance with applicable regulations (Change Control).
Reviews protocols and reports to support regulatory compliance and submissions.
Reviews device labeling and advertising materials for compliance with FDA submissions and applicable regulations.
Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body).
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Performs other related duties and responsibilities, on occasion, as assigned.
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelor’s degree (BS, BA) (technical discipline preferred) with at least 8 years’ technical experience.
Minimum six years’ medical device regulatory experience.
Experience working in a broader enterprise/cross-division business unit model preferred
Extensive experience with US and global medical device regulations and submissions.
Experience working in a broader enterprise/cross division business unit model preferred.
Ability to work in a highly matrixed and geographically diverse business environment.
Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
Ability to work effectively within a team in a fast-paced changing environment.
Strong organizational, planning, and follow-up skills and ability to hold others accountable.
Ability to travel approximately 15%, including internationally.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
Training and career development , with onboarding programs for new employees and tuition assistance
Financial security through competitive compensation, incentives and retirement plans
Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Paid time off
401(k) retirement savings with a generous company match
The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com at http://www.abbottbenefits.com/pages/candidate.aspx
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com at http://www.abbott.com/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com