IrvingRecruiter Since 2001
the smart solution for Irving jobs

Sr. Regulatory Affairs Specialist - Medical Device

Company: Abbott Laboratories
Location: Irving
Posted on: January 12, 2021

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 107,000 colleagues serve people in more than 160 countriesABOUT 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 ROLEAs 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 approvalPostmarket:* 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 communicationsEDUCATION AND EXPERIENCE YOU'LL BRINGRequired* Bachelor's Degree (or equivalent); Bachelor's Degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) * 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. * 3-4 years' experience in a regulated industry (e.g., medical products, nutritionals). * MDSAP knowledge a plus. ISO13485, IEC61010, ISO 9001 knowledge. * Change control, Engineering Controls, Risk Management 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.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 communitiesLearn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.comFollow 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.

Keywords: Abbott Laboratories, Irving , Sr. Regulatory Affairs Specialist - Medical Device, Other , Irving, Texas

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


RN Transfer Center
Description: Job DescriptionDescription Summary: The CHRISTUS Transfer Center RN
Company: CHRISTUS Health
Location: Tyler
Posted on: 01/22/2021

Patient Care Tech - Med Surg - FT Nights
Description: Palestine Regional Medical CenterUnder supervision of a licensed nurse or with delegated responsibility from
Company: Palestine Regional Medical Center
Location: Palestine
Posted on: 01/22/2021

KFC Team Member
Description: Description:At KFC, we feed the world. But we do more than fill people up. We fulfill their life. Our meals matter, and when we serve them with southern hospitality, we make our customer's day. So our (more...)
Company: KFC Kentucky Fried Chicken
Location: Sulphur Springs
Posted on: 01/22/2021


RN, CVICU, PRN
Description: Job DescriptionAdvancing Healthcare Together - The Future of Healthcare is in East Texas Why UT Health - East Texas Our People. Our people truly are our greatest strength. They make a massive difference (more...)
Company: UT Health East Texas
Location: Tyler
Posted on: 01/22/2021

Quality Assurance Supervisor Tyler TX
Description: Kelly Services is seeking a Quality Assurance Supervisor for a prominent poultry and beef manufacturing facility in Tyler, TX br br Job Title: QA Supervisor br Location: Tyler, TX 75703 br Type: (more...)
Company: Kelly
Location: Tyler
Posted on: 01/22/2021

Earn more this Winter, deliver with Uber Eats
Description: Job DescriptionDeliver with Uber. Earn on your schedule. Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekends it's up to you. Earn Good Money. You'll
Company: Uber Eats
Location: Palestine
Posted on: 01/22/2021

Remote Work-From-Home Independent Contractor
Description: We got what you want, you got what we need Goodbye long commutes, rigid schedules, and busybody managers. Hello, Liveops. Our well-known clients are seeking Independent Contractors to provide virtual (more...)
Company: Liveops
Location: Overton
Posted on: 01/22/2021

Favor Delivery Runner
Description: Are you looking for a flexible way to earn extra cash daily, make your own schedule, and provide a great experience to customers, all while having fun
Company: Favor
Location: Wells
Posted on: 01/22/2021

Get New Installing/Repairing Window Work Today - Preview Leads In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: Tyler
Posted on: 01/22/2021

Remote Work-From-Home Independent Contractor - Call Center Representative
Description: We got what you want, you got what we need Goodbye long commutes, rigid schedules, and busybody managers. Hello, Liveops.Our well-known clients are seeking Independent Contractors to provide virtual services (more...)
Company: Liveops
Location: Winnsboro
Posted on: 01/22/2021

Log In or Create An Account

Get the latest Texas jobs by following @recnetTX on Twitter!

Irving RSS job feeds