Regulatory Affairs Specialist I – Neuromodulation (on-site)

Abbott Laboratories hiring for Regulatory Affairs Specialist I – Neuromodulation (on-site) jobs in Plano, TX, US

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 114,000 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 includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.

We are presently hiring for a Regulatory Affairs Specialist I to work on-site 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.
• May interface directly with FDA and other regulatory agencies.
• Work with cross-functional team to support product release process.
• Reviews protocols and reports to support regulatory submissions.
• 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.
• 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.
• Establishes and cultivates an extensive network of support to facilitate completion of assignments.
• Participates in determining goals and objectives for projects.
• Exercises judgment in selecting innovative, practical methods to achieve problem resolution.

Required Qualifications

• Bachelor’s degree or an equivalent combination of education and experience
• 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 and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. 
• Multitasks, prioritizes and meets deadlines in timely manner. 
• Strong organizational and follow-up skills, as well as attention to detail. 

Preferred Qualifications

• Bachelor's degree in science (such as biology, chemistry, microbiology, neuroscience), math, engineering, or medical fields. 
• 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.
• Ability to critically think through complex problem statements.
• Experience writing clear and concise technical documents.
• 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:  www.abbottbenefits.com

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $48,000.00 – $96,000.00. In specific locations, the pay range may vary from the range posted.