Regulatory Affairs Specialist

Abbott

Pleasanton (CA)

On-site

USD 74,000 - 116,000

Full time

14 days+

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Benefits offered by this job

Free HIP PPO medical plan next year

Excellent retirement savings with high

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Regulatory Affairs Specialist for the Pleasanton, CA area to support the Heart Failure division. As an individual contributor, you will assist regulatory submissions, manage documentation, and liaise across functions to maintain approvals and licensing for medical devices.

You will interact with regulatory agencies, ensure compliance with FDA and global requirements, and contribute to timely product registrations while supporting quality systems and EMS within a matrixed,

Qualifications

Bachelor’s Degree or equivalent in a technical discipline.
No experience or some experience in medical device industry.
Ability to work in a matrixed, fast-paced environment and communicate across levels.

Responsibilities

Submit product registrations and manage regulatory submissions.
Collaborate with cross-functional teams to support product licensing and documentation.
Support product release by processing licenses and release requests.
Serve as regulatory liaison throughout product lifecycle.
Ensure timely approvals of medical devices and continued product approvals.

Skills

Regulatory affairs knowledge

Strong verbal and written comms

Cross-functional collaboration

Attention to detail

Education

Bachelor's Degree in technical discipline or equivalent

Master’s Degree in science/engineering preferred

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 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’llalso 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 debtprogramand FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree

A company recognized asa great placeto 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 tomonitoringand treatment.

The Opportunity

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

As an individual contributor, the Regulatory Affairs Specialist will support productregistrationand regulatory activities.

WhatYou’llWork On

Asaprofessional in the Regulatory Affairs Sub-Function,possessesdevelopingskills in product registration submission,change ordermanagement,progress reports.
Interacts withregulatory affairs team members andothercross functional team membersforregulatory submissions, productlicensingandrelevantdocumentation.
Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
Servesasregulatoryliaison throughout product lifecycle.
Ensurestimelyapproval of medical devices and continued approval of marketed products.
May interface with regulatory agencies.
Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
Creates,reviewsand approves engineering change orders.
Reviews protocols and reports to support regulatory submissions.
Supports all business segment initiatives asidentifiedby 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.
Maintainspositive 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 toleverageand/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 deadlinesin 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). Regulatoryarea ispreferred but may consider quality assurance, research and development/support, scientific affairs, operations, or relatedarea.
Regulatory Knowledge of:
Regulatory history, guidelines, policies, standards, practices,requirementsand precedents.
Regulatory agency structure,processesand key personnel.
Principles and requirements of applicable product laws.
Submission/registrationtypes and requirements.
GxPs (GCPs, GLPs, GMPs).
Principles and requirementsofpromotion,advertisingand 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.
Meetdeadlines.
Think analytically and critically.
Review and analyze documentation.
Research andlocateinformation on regulatory requirements and products.
Exercise judgment within defined procedures and practices to determine appropriate action.
Has general knowledge of technical alternatives andgainan understanding of their impact on the systems environment.
Apply business ethical standards.