Regulatory Affairs 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

ThispositionservesastheMedical DevicesRegulatoryAffairs(RA)GlobalRegulatoryComplianceprocesslead;collaboratescross-functionallyasneededandkeepsMD RAinformedofkeyglobalregulatorychangesandstatusofassessment/implementationforcomplianceviatheQMSProcess.

WHAT YOULL DO

Global Regulatory Operations is seeking aRegulatory Affairs Intelligence Specialistto join our team in St. Paul MN.

This position is focused on new and changing regulations that enable global market access for new and innovative medical devices and supports compliance continuity for marketed devices.Assistingin the process to evaluate proposed regulatory changes in major markets including the US EU Canada Australia Brazil Japan the Regulatory Affairs Intelligence Specialist:

• Monitors and fact-checks new or changing global regulations

• Tracks and documents regulations within the regulatory intelligence systems

• Supports the communication of emerging regulations documents for comment and regulations in implementation

• Performs regulatory investigations to assess medical device regulatory changes within a specific country or region

• Supports the maintenance of or continuous improvement of quality system procedures and documents

• May train others on systems and processes

• Facilitates the collection and reporting of data in support of key performance indicators

• Gathersadditionaldata to support interpretation and aid businesses indeterminingimpact

• Support all company initiatives asidentifiedby management and in support of Quality Management Systems (QMS) and other regulatory requirements

• Complies withregulations international regulations and other regulatory requirements company policies operating procedures processes and task assignments.

• Maintains positive and cooperative communications and collaboration with all levels of employees customers contractors etc.

• Performs other related duties and responsibilities on occasion as assigned

Required Qualifications

• BachelorsDegree (2years) In science (biology chemistry microbiology immunology medical technology pharmacy pharmacology) math engineering or medical fields is preferred OR an equivalent combination of education and work experience

• Minimum 2 years This position does not requirepreviousregulatory experience. 2-3years experiencein a regulated industry (e.g. medical products nutritionals). Regulatoryarea ispreferred but may consider quality assurance research and development/support scientific affairs operations or relatedarea.

• Experience with Regulatory history guidelines policies standards practices requirements and precedents; Regulatory agency structureprocessesand 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; Domestic and international regulatory guidelines policies and regulations; Ethical guidelines of the regulatory profession clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position.

• Communicate effectively verbally and in writing. Communicate with diverse audiences andpersonnel. Write and edit technical documents.

• Work with cross-functional teams. Work with people from various disciplines and cultures.

• Write and edit technical documents.

• Negotiate internally.

• Pay strong attention to detail.

• Manage projects. Create project plans and timelines.

• Think analytically and critically.

• Organize and track complex information.

• Exercise judgment withingenerally definedpractices and policies in selecting methods andtechniques for obtaining solutions.

• Has a sound knowledge of a variety of alternatives and their impact on the business.

• Apply business and regulatory ethical standards.

• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.

Preferred Qualifications

• 2-4 yearsexperience inmedicaldevices 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