Senior Regulatory Affairs Specialist

Abbott Laboratories Austin , TX 78719

Posted 2 months ago

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 Sr. Regulatory Affairs Specialist. This position leads the strategy, preparation, and submission for worldwide regulatory approvals and acts independently to identify and resolve problems. Provides regulatory guidance to cross-functional partners and demonstrates strategic thinking and creativity in support of programs.

WHAT YOU'LL DO

  • Prepares robust regulatory applications to achieve departmental and organizational objectives

  • Creates, reviews and approves engineering change orders

  • Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team

  • Provides guidance and expertise

  • Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail

  • Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems

  • Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations

  • Interfaces directly with FDA and other regulatory agencies
  • Supports the product release process by creating GTS licenses or reviewing and approving requests for product release

  • Conducts reviews of product and manufacturing changes for compliance with applicable regulations

  • Reviews protocols and reports to support regulatory submissions

EDUCATION AND EXPERIENCE YOU'LL BRING

Required:

  • BA or BS degree

  • A minimum of 5 years of technical experience, including at least 4 years of regulatory experience in a medical device industry -

  • Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

  • Ability to travel approximately 5%, including internationally

Preferred:

  • Degree in a technical discipline highly preferred

  • Experience working in a broader enterprise/cross-division business unit model preferred

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • A fast-paced work environment

  • 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

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, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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Senior Regulatory Affairs Specialist

Abbott Laboratories