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Abbott · 1 month ago

Regulatory Specialist II

Scarborough, ME

Contract

Onsite

Mid Level

4+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. The Regulatory Specialist II will be responsible for providing regulatory support for diagnostic product development and ensuring compliance with EU and international regulations.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR)

Provides regulatory support for diagnostic product development and commercial diagnostic products

Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally

Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments

Researches and communicates scientific and regulatory information in order to write submission documents

Compiles and publishes all material required for submissions, license renewals, and annual registrations

Maintains approvals/licenses/authorizations for existing marketing authorizations

Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations

Develops internal procedures and tools

Conducts informational or training sessions for stakeholders

Organizes and maintains hard copy and electronic department files

Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies

Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices

Qualification

IVDR knowledgeEU regulatory requirementsRegulatory Affairs experienceIVD manufacturing experienceMicrosoft Office proficiencyWritten communication skillsVerbal communication skillsTime management skillsTeamwork abilityIndependent work ability

Required

Bachelor's degree in biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience

4+ years' experience in Regulatory Affairs role

Strong knowledge of IVDR and EU regulatory requirements is required