Regulatory Affairs Specialist I

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.
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, SCS 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.
Our location in Plano, TX is looking for a Regulatory Specialist I. 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.
What You’ll Do

• Reviews protocols and reports to support regulatory submissions.
• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates.
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Work with cross-functional team to support product release process.
• 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.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Maintains 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. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• Prepares robust regulatory applications for Class II or Class III devices (either for FDA, EU, or other international regulatory agencies) to achieve departmental and organizational objectives.
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
• May interface directly with FDA and other regulatory agencies.

Required
EDUCATION AND EXPERIENCE YOU’LL BRING

• Bachelor’s degree or an equivalent combination of education and experience
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong organizational and follow-up skills, as well as attention to detail.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Ability to leverage and/or engage others to accomplish projects.

Preferred

• Bachelor’s degree or higher in a technical discipline (science, biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, math, engineering, etc.
• Experience writing clear and concise technical documents.
• Experience with medical device industry
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Proficient with MS Office suite (Word, Excel, Outlook)
• Experience working in a broader enterprise/cross-division business unit model
• 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 critically think through complex problem statements.

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
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs. 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.
• Paid time off
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities
• Financial security through competitive compensation, incentives and retirement plans
• 401(k) retirement savings with a generous company match

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.