Quality , Science, Pharmaceutical & Food

Regulatory Affairs Manager – Galway

  • Contract
  • Remote
  • Galway
  • 41926359

PE Global are currently recruiting for a Senior Regulatory Affairs Specialist for a client site in Galway  –

Senior Reg Affairs role Looking for someone with at least 3 years experience 12 month contract

JOB SUMMARY
The Senior Regulatory Affairs Specialist provides independent regulatory guidance to product
development teams on International pre-marketing applications, and any related submissions to
support optimal timelines for new/modified product launches and ongoing regulatory compliance.

DUTIES & RESPONSIBILITIES
• Guides conformance with applicable regulations in product development, support of claims, content
labelling, and promotional materials. The role assists in the development of best practices for Regulatory Affairs processes.
• Helps define data and information needed for regulatory approvals in conjunction with cross-functional
product development teams.
• Leverages a deep scientific and technical understanding of regulated products under scope of
responsibility to provide strategic guidance and support for product development and life-cycle
management of products (e.g. represents Regulatory in the complaint handling and field action process).
• Clearly defines and prioritises decision criteria, considers the benefits and risks of each solution before
making decisions. Considers all of the available facts when situations are ambiguous in order to make the
best possible decision.
• Develops labelling specifications and approves proposed labelling and packaging, after evaluating
conformance to regulations is required.
• Ensures compliance with regulatory agency regulations and interpretations.
• Prepares responses to regulatory agencies’ questions and other correspondence.
• Provides regulatory advice to project teams.
• Guides conformance with applicable regulations in product development, support of claims and label
content.
• Defines data and information needed for regulatory approvals. Gathers and assembles information
necessary for submissions in accordance with regulations and relevant guidelines.
• Assist in the development of product reimbursement strategies. Lead applications for product
reimbursements in line with company strategies.
• Provides Regulatory Affairs support during internal and external audits.
• Represents Regulatory Affairs on cross-functional project teams.

EXPERIENCE AND EDUCATION
• Minimum 3 years’ experience in the medical device industry, with at least 2 years in a position in
regulatory affairs or related/equivalent field.
• Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied
audience the regulatory or quality function.
• Experience of inspection by an external agency, such as the FDA.
• Ability to work well under deadlines and pressure.
• Demonstrated track record in:
− Submission of licenses and authorizations for the maintenance of existing products
− International registrations and dossiers
− Execution of regulatory strategies that align with business deliverables.

REQUIREMENTS
• Knowledge/working experience of the European Medical Device Directive/Regulation (EU MDD
93/42/EEC and EU MDR 2017/745), FDA’s 21 CFR Part 812 (Investigational Device Exemption), 21 CFR
Part 807 (Premarket Notifications), 21 CFR Part 814 (Premarket Approval), and relevant European and
US regulations and standards, including Quality System requirements, such as 21 CFR Part 820 (Quality
System Regulation), EN ISO 13485, etc.
• Knowledge of other applicable medical device regulations, e.g. Brazilian, Canadian, Australian,
Japanese, Korean, etc., advantageous.
• Excellent interpersonal skills and ability to work with people to achieve results.
• Excellent written and communication skills, fluency in English.
• Good judgment/decision making and problem-solving ability, capable of understanding the impact of
decision making on both client and their customers.
• Motivated and an enthusiastic self-starter with the ability to work under own initiative and as a team player.

 

Interested candidates should send their CV to Audrey.mccarthy@peglobal.net or call 0214297900

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