Senior Regulatory Intelligence Specialist

Working at Abbott

• At Abbott you can do work that matters grow and learn care for yourself and your family be your true self and live a full life.Youllalso have access to:

• Career development with an international company where you can grow the career you dream of.

• Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.

• An excellent retirement savings plan with a high employer contribution

• Tuition reimbursement the Freedom 2 Save student debt program andFreeUeducation benefit - an affordable and convenient path to getting a bachelors degree.

• A company recognized asa great placeto work in dozens of countries worldwide 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 the best place to work for diversity working mothers female executives and scientists.

The Opportunity

ThispositionservesastheStructuralHeart(SH)RegulatoryAffairs(RA)GlobalRegulatoryComplianceprocesslead;collaboratescross-functionallyasneededandkeepsSH RAinformedofkeyglobalregulatorychangesandstatusofassessment/implementationforcomplianceviatheQMSProcess.

Main Responsibilities

ActsasSHRArepresentativeforRAcompliancerelatedtasksincross-functionalteam.

Activelyparticipatesinall meetings anddiscussions andtrack assessment and implementation to completion

Act as RA point of contact forcurrent knowledge of global regulatorychanges

Review complex documents and literature for regulatory bodies to gain andmaintaincompliance

Collaborate withcross-functional teamtoidentifyassessand implement necessary regulatory changes

Activelyparticipatein all Global Regulatory Compliance team meetings and be prepared to summarize and communicate key highlights to the broader team including project planning documentation task completion updates and issues requiring resolution.

Perform regulatory product submissions for projects covering multiple product linesas needed.

Assistteam in IFUCompetitiveAnalysis and ReviewProjects asneeded

ReviewClinicaldocumentsandliteraturefor RA asneeded

SupportsallbusinesssegmentinitiativesasidentifiedbydivisionalmanagementandinsupportofQuality Management Systems (QMS)EnvironmentalManagement Systems (EMS)andotherregulatoryrequirements

ComplieswithU.S. FoodandDrugAdministration (FDA)andinternationalregulationsotherregulatoryrequirements .

ProvidesmentoringandleadershiptoRegulatorySpecialistIandIIteammembers

Required Qualifications

• BachelorsDegree(16years)intechnicaldisciplinehighlypreferredORanequivalentcombinationofeducationandworkexperience

• Minimum5yearsof technicalexperienceincludingatleast4yearsofregulatoryexperienceinthe medicaldeviceindustry.

• Experience with leading/collaboratingwith cross-functionalteams toachieveproject completion

• Proficient use of Microsoft Suite products(SharePoint experience is preferred)

• Experience incross-collaboration withinGlobal Regulatory environment

• Proven highly effectivecommunication skills in all mediaand excellent interpersonal skills

• High attention to detail with excellent critical thinking skills

• Excellentfollow through skills for reaching completion of tasks.

• 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 othersto accomplishprojects. Strong verbal and written communications withabilityto effectively communicate at multiple levels in the organization. Multitasksprioritizesand meets deadlines intimelymanner. Strong organizational and follow-up skills as well as attention to detail.

• Abilitytotravelapproximately5%includinginternationally.

Preferred Qualifications

• Experience in Medical Devices or a regulated industry (e.g. nutritional pharma)preferred. Experience in a Regulatory or Quality role a plus.

• Ability to work within a fast-paced and matrixed team environment

• Strong verbal and written communication skills Strong attention to detail and organizational skills

• Proficient in Excel and all programs with MS Office suite (Word PowerPoint Outlook)

• Experience in program management a plus

• Experience with document management systems a plus