Regulatory Affairs Specialist II– Neuromodulation

Posted Jan 18
Full Time
Plano, Texas
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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 115,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, You Can Do Work That Matters, Grow, And Learn, Care For Yourself And Family, Be Your True Self And Live a Full Life. You’ll Also Have Access To

  • Career development with an international company where you can grow the career you dream of.
  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Our Neuromodulation business is a market leader in leveraging mobile, minimally-invasive implantable technologies to help people who suffer from chronic pain and movement disorders. Our chronic pain solutions include the Eterna™ System, Proclaim™ XR SCS System, Proclaim™ DRG Neurostimulator, the only FDA approved DRG therapy, and the IonicRF™ Generator for Radiofrequency Ablation. 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.

We are presently hiring for a Regulatory Affairs Specialist II at our location in either Plano or Austin, Texas. This new team member performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Additionally, will support necessary regulatory activities required for product market entry.

The Opportunity

As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support for the Regulatory Affairs department to ensure efficient and compliant business processes and environment. The individual may execute tasks and partner across business functions.

What You’ll Work On

  • Provide regulatory input to product lifecycle planning.
  • Partner with cross-functional teams to define scope and assess strategies for maintaining the total product lifecycle – including pre-market development and post-market changes. Apply principles of design control and knowledge of regulations to guide teams to successful regulatory reviews.
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes for medical devices.
  • Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
  • Anticipate and navigate regulatory obstacles based on information from international agencies and trends in regulatory environment
  • Determine and communicate submission and approval requirements. Monitor applications under regulatory review.
  • Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies.
  • Write, prepare, and review regulatory submissions to authorities.
  • Maintain annual licenses, registrations, and listings.
  • Assist compliance with product post-market approval requirements.
  • Assess external communications relative to regulations. Review regulatory aspects of contracts.
  • Assist with label development and review for compliance before release.
  • Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel. Plans and organizes non-routine tasks w/approval. Establishes priorities of work assignments. May lead a departmental project team.
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.
  • Participates in determining goals and objectives for projects.
  • Influences middle management on technical or business solutions.
  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution.

Required Qualifications

  • Bachelor's degree or an equivalent combination of education and work experience
  • Minimum 3 years’ related experience including a minimum of two years regulatory experience.
  • Experience with either 510(k) applications, PMA supplements and US device regulations or with EU and other international medical device regulations and submissions.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage, manage and/or engage others to accomplish projects.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Multitasks, prioritizes and meets deadlines in a timely manner.

Preferred Qualifications

  • Bachelor's degree in science/technical discipline (engineering, life sciences, mathematics).
  • Master’s degree in science or regulatory
  • 1+ year of Regulatory Affairs experience within Medical Devices, including FDA submission (e.g. 510(k), PMA-supplement, IDE) and EU MDR experience
  • Working knowledge of QSR820, ISO 13485, and Design Controls
  • Experience working in a broader enterprise/cross-division business unit model.
  • Experience working in the Medical Device industry.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Apply Now

  • Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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The base pay for this position is $57,300.00 – $114,700.00. In specific locations, the pay range may vary from the range posted.