Senior Regulatory Specialist

Abbott

Pleasanton (CA)

On-site

USD 90,000 - 180,000

Full time

14 days+

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Benefits offered by this job

Health coverage

Retirement plan

Tuition reimbursement

Job summary

Abbott in Pleasanton, CA is seeking a Senior Regulatory Affairs Specialist to support regulatory submissions and liaise with FDA and other agencies. This role contributes to product development and lifecycle management within the Heart Failure division.

The position requires a technical degree with 4+ years in regulatory affairs for medical devices, strong communication, and the ability to work in a matrixed environment. Travel ~5% is expected.

Qualifications

Bachelor level technical degree required or equivalent
4+ years regulatory experience in medical devices
Experience with 510(k) and PMA submissions; US and international regs
Strong communication and cross-functional collaboration skills

Responsibilities

Lead regulatory submission activities for product registrations and updates
Interact with FDA and other regulators to expedite approvals
Serve as regulatory liaison across product lifecycle and marketing teams
Support product release processes and change control in line with regulations

Skills

Verbal communication

Written communication

Time management

Education

Bachelor's degree in a technical discipline

Master's Degree in Regulatory Affairs

Tools

Word

Excel

PowerPoint

Adobe Acrobat

SharePoint

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 114,000 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 Senior Regulatory Affairs Specialist will work out of our Pleasanton, CA location in theHeart FailureDivision. As an individual contributorinthe function of a Sr. 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 Senior Regulatory Affairs Specialist will support product development and regulatory activities.

WhatYou’llWork On

As the Experienced professional in the Regulatory Affairs Sub-Function,possesseswell developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Interacts withFDA and otherregulatory agency toexpediteapproval of pending registration.
Serves asregulatoryliaison throughout product lifecycle.
Participatesin some of the following: product plan development and implementation, regulatory strategy, risk management,
Ensurestimelyapproval ofmedical devices and continued approval of marketed products.
Interfaces directly with FDA and other regulatory agencies.
Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
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 withU.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Companypolicies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications andcollaboration with all levels of employees, customers, contractors, and vendors.
Serves as regulatory representative to marketing, researchteamsand regulatory agencies.
Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling,appropriate regulationsand interpretations.

Required Qualifications

BachelorsDegree (± 16 years) Technical discipline highlypreferredOR an equivalent combination ofeducation and work experience
Minimum 5 yearsTechnicalexperience, including at least 4 years of regulatory experience in a medicaldevice industry.
Experience with 510(k) applications, PMAsupplementsand US device regulations and/or
experience with EU and other international medical device regulations and submissions.
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, changingenvironment.
Ability toleverageand/or engage othersto accomplishprojects.
Strong verbal and written communication withabilityto effectively communicate at multiple levels in theorganization.
Multitasks,prioritizesand meets deadlines intimelymanner.
Strongorganizationand follow-up skills, as well as attention to detail.
Ability to travel approximately 5%, includinginternationally.

Preferred Qualifications

MastersDegree (± 18 years), In Regulatory Affairs preferred and may be used in lieu of direct regulatoryexperience.Minimum3 years, 3-4years experiencein 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 relatedarea. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
Experience with review of labeling, promotional, and or advertising materials is highly desired
Familiar withPrinciples and requirements ofpromotion,advertisingand labeling.
Office program skillsto includeWord, Excel, PowerPoint, AdobeAcrobatand SharePoint.
Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), regulatory affairs, engineering, or medical fields.Master’s Degree in Regulatory Affairs and may be used in lieu of direct regulatory experience.

The base pay for this position is

$90,000.00 – $180,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

HF Heart Failure

LOCATION:

United States > Pleasanton : 6101 Stoneridge Dr

WORK SHIFT:

Standard

TRAVEL: