Regulatory Affairs Specialist

5 months ago

Galway, Ireland Abbott Full time

About Abbott

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 109,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 6,000 people across ten sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry-leading technologies to support diagnostic testing which provides important information for the treatment and management of diseases and other conditions. IDEM is an over a billion-dollar business unit that now support significate growth for Abbott in COVID-19 related products in over 70+ countries.

PURPOSE OF THE JOB

The Regulatory Affairs Specialist provides a support role to the IDEM Business Unit, their Manufacturing Site and key project activities. The Regulatory Affairs Specialist reports to the Manager of Regulatory Affairs. The role is based in Galway, Ireland.

This position applies advanced regulatory expertise in the Medical Device / IVD area to guide cross-functional partners and demonstrates strategic thinking and creativity in support of key business programs as a legal manufacturing site. This site will act as the legal manufacturing site and Authorized Representative site for the IDEM non-EU based physical manufacturing sites.

MAJOR RESPONSIBILITIES

As part of the IDEM Business Unit Regulatory Affairs team, 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. This includes supporting global certification activities and regulatory compliance activities, including manufacturing site registration, external regulatory agency audits and internal audits as needed.

Coordinates change reviews with international RA teams to determine global change impact and consequent submission requirements by sending out change notification to the teams, compiling responses and documenting them within the appropriate QMS system

Reviews complaints, provides regulatory assessments and completes associated reporting to relevant agencies as per the applicable regulatory reporting requirements globally

Identifies and develops best practices within the Regulatory Affairs department including continuous development initiatives

Ensures personal understanding of all quality policy/system items that are personally applicable and carries out duties in compliance with established business policies.

Follows all work/quality procedures to ensure quality system compliance and high-quality work.

Collaborate with cross-functional global teams functional teams including but not limited to: IVDR teams, EU Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met, prior to product release

Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Develop and maintain strong and effective relations with internal/external personnel

Other duties as assigned, according to the changing needs of the business

EDUCATION AND COMPETENCIES REQUIRED

Minimum of a Bachelor’s Degree (BA/BS) from an accredited University

Minimum of (2) years of experience in Regulatory Affairs role within a GMP / Biotech / Pharma / Medical Device/ IVD/ Regulated Industry.

PREFERRED QUALIFICATIONS AND COMPETENCIES

Regulatory experience is desirable, however, candidates with a relevant experience will also be considered.

Strong written and verbal communication skills

Demonstrated success in the GMP / Biotech / Pharma / Regulated Industry.

Ability to adapt quickly and effectively to shifting priorities.

Very strong attention to detail

Must be able to productively generate quality documentation to meet Program timelines

Flexible scheduling (if needed and advance notice is given)

Strong skills in Microsoft Office, especially in Word, Excel, and PowerPoint

Excellent knowledge of Quality/Regulatory requirements in the IVD / Medical Device Industry including Medical Device and IVD Regulations, ISO13485, 21CFR820, ISO14971 and other standards and regulations applicable to IVD / Medical Devices.

Adaptability, Innovation, Initiative, Teamwork, Quality of Work, Commitment

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