Regulatory Affairs Specialist

About this role

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. JOB DESCRIPTION: 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   

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.   

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 mission is to help people with heart failure survive and thrive. At Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to   monitoring   and treatment.   

The Opportunity    

This   Regulatory Affairs Specialist   will work out of our Pleasanton, CA location in the Heart Failure Division. As an individual contributor   in   the function of a Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department. With limited   supervision   you will execute tasks and partner across business functions.   

As an individual contributor, the Regulatory Affairs Specialist will support product   registration   and regulatory activities .    

What   You’ll   Work On      • As   a   professional in the Regulatory Affairs Sub-Function,   possesses   develop ing   skills in product registration submission,   change order   management,   progress reports.     • Interacts with   regulatory affairs team members and   other   cross functional team members   for   regulatory submissions , product   licensing   and   relevant   documentation .     • Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.  

• Serves   as   regulatory   liaison throughout product lifecycle.     • Ensures   timely   approval of medical devices and continued approval of marketed products.   

•   May i nterface with regulatory agencies.   

• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.   

• Creates,   reviews   and approves engineering change orders.   

• Reviews protocols and reports to support regulatory submissions.   

• Supports all business segment initiatives as   identified   by divisional 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      

Required Qualifications     

• Bachelor's Degree (± 16 years), Technical discipline preferred OR an equivalent combination of education and work experience  

• No Experience, some experience with medical device industry preferred.  

• Experience working in a broader enterprise/cross-division business unit model preferred. 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 in accomplishing projects. Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes, and meets deadlines   in a timely manner . Strong organizational and follow-up skills, as well as attention to detail.  

Preferred Qualifications     

• Master’s Degree (± 18 years), In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred  

• 2 years, In a regulated industry (e.g., medical products, nutritionals). Regulatory   area is   preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related   area .  

• Regulatory Knowledge of:     Regulatory history, guidelines, policies, standards, practices,   requirements   and precedents.     Regulatory agency structure,   processes   and key personnel.     Principles and requirements of applicable product laws.     Submission/ registration   types and requirements.     GxPs (GCPs, GLPs, GMPs).     Principles and requirements   of   promotion,   advertising   and labeling. Note: This knowledge may be developed through tenure in this position.     Communication Skills or Ability to:     Communicate effectively verbally and in writing.     Learn to write and edit technical documents.     Work with cross-functional teams.     Work with people from various disciplines and cultures.     Cognitive Skills or Ability to:     Pay strong attention to detail.     Handle detailed tasks and prioritize them.     Meet   deadlines .     Think analytically and critically.     Review and analyze documentation.     Research and

Similar jobs

• Regulatory Affairs Specialist — Medtronic · Mounds View, Minnesota, United States | North Haven, Connecticut, United States | Boston, Massachusetts, United States
• Regulatory Affairs Specialist — Medline · Remote
• Regulatory Affairs Specialist — Envista · Brea, California, United States
• Regulatory Affairs Specialist — Dexcom · San Diego, California
• Senior Regulatory Affairs Specialist — Dexcom · San Diego, California
• Senior Regulatory Affairs Specialist — Oura · Remote
• Senior Regulatory Affairs Specialist — Iovancebiotherapeutics · Remote
• Senior Regulatory Affairs Specialist — Siemens Healthineers · Remote