Sr. Regulatory Affairs Specialist - Medical Device

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Job description

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 109,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

ABOUT ABBOTT DIAGNOSTICS:

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott's life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations - with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Our location in Irving, TX currently has an opportunity for a Sr. Regulatory Affairs Specialist .

MAIN PURPOSE OF ROLE

As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

WHAT YOU'LL DO

• Leverage MS Excel and project management tools to track and provide team updates on progress against project deliverables. Facilitate negotiations to what is aggressively achievable to exceed Division timeline expectations.
• Update Regulatory Information System as information is acquired to support future submissions.
• Work with project team to develop key deliverables that need to be tracked and managed. Manage detailed plans and anticipate possible road blocks to meeting plan.
• Regulatory Assess hardware and software changes to determine impact on on-market products.
• Approve Global Service and Support Technical Service Bulletins
• Participate on cross-functional teams as the Subject Matter Expert
• Assess emerging Regulations against Quality System. Perform a Regulatory Assessment and recommendation.

Premarket:

• Work with project team to develop key deliverables that need to be tracked and managed. Manage detailed plans and anticipate possible road blocks to meeting plan.
• Take ownership of the project and develop effective working relationships and communication with team members and business partners to develop plans to meet the timelines, then follow up on those deliverables to hold self and others accountable for commitments.
• Work independently and with team members to identify and then mitigate risks/issues.
• Assess the acceptability of quality, technical documentation for 510(k) submissions and PMA 180-day Supplements
• Compile, prepare, review and submit regulatory submission to authorities
• Monitor impact of changing regulations on submission strategies
• Monitor applications under regulatory review
• Monitor and submit applicable reports to regulatory authorities
• Evaluate proposed Engineering manufacturing changes for regulatory filing strategies
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval

Postmarket:

• Maintain annual licenses, registrations, and listings
• Assist compliance with product post-marketing approval requirements; Experience in CAPA
• Review and approve advertising and promotional items to ensure regulatory compliance
• Assess external communications relative to regulations
• Review regulatory aspects of contracts
• Assist with label development and review for compliance before release
• Submit and review change controls to determine the level of change and consequent submission requirements
• Analyze the input of cumulative product changes to current product submissions
• Ensure product safety issues and product-associated events are reported to regulatory agencies
• Provide regulatory input for product recalls and recall communications

EDUCATION AND EXPERIENCE YOU'LL BRING

Required

• Bachelor's degree in a related field or an equivalent combination of education and work experience
• Master's degree on regulatory affairs preferred and may be used in lieu of direct regulatory experience.
• 3-4 years' experience in a regulated industry (e.g., medical products, nutritionals).
• 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.

Preferred

• Bachelor's Degree in Engineering (e.g. Mechanical, Electrical, or similar), highly preferred.
• 3 (+) years' above Regulatory work experience from medical device industry or similar industry.
• MDSAP knowledge a plus. ISO13485, IEC61010, ISO 9001 knowledge.
• Change control, Engineering Controls, Risk Management
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

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
• Pension Plan
• 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:

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 , on Facebook at and on

JOB FAMILY:
Regulatory Operations

DIVISION:
ADD Diagnostics

LOCATION:
United States > Irving : LC-8

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
No

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English:

EEO is the Law link - Espanol: