Regulatory Affairs Specialist at Abbott

Galway, County Galway, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, Diagnostics, PharmaceuticalsIndustries

Requirements

Advanced regulatory expertise in the Medical Device / IVD area
Ability to guide cross-functional partners with strategic thinking and creativity in support of key business programs
Based in Galway, Ireland (role location)

Responsibilities

Provides regulatory support for new products and changes to existing products to ensure efficient and compliant business processes and environment
Assists in preparation of regulatory documents including Technical Documentation and Design Dossiers for CE marked and WHO prequalified products
With guidance from RA Manager, updates and maintains Technical Documentation and Design Dossiers for CE marked and WHO prequalified products
Prepares and submits product registration files to International RA teams in order to obtain and maintain marketing authorisations worldwide
Works closely with relevant manufacturing sites and other functions to obtain all the necessary documents to support product registration, renewal or amendment to existing product certificates in a timely manner
Provides post market maintenance support to commercial products as necessary to ensure ongoing regulatory approval, including supporting global certification activities and regulatory compliance activities, such as manufacturing site registration, external regulatory agency audits and internal audits as needed
Coordinates change reviews with international RA teams to determine global impacts

Skills

Regulatory Affairs

Compliance

Medical Devices

Diagnostics

Quality Assurance

Healthcare Regulations

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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