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RA Manager

Job Seekers Ireland Science Life Science

Job Summary

  • Republic of Ireland
  • Permanent
  • BBBH795356
  • Oct 12, 2021
  • Competitive
Job Description

Excellent opportunity for an experienced Senior Regulatory Specialist to take the next step in their career. See below for further details!

In partnership with our client, a global Medical Device company based in Cork, we are now hiring a Regulatory Affairs manager. This position can be fully remote or hybrid.

Key responsibilities

  • Manage and/or prepare device regulatory filings with a thorough understanding of the US FDA and EU (MDD/MDR) regulatory requirements.
  • Review and assess facility change controls for potential impact on current medical device regulatory filings in US (Class II and III), EU (Class IIa and IIb), and Rest of World.
  • Provides high quality regulatory support for assigned products/projects.
  • Coordination and establishment of global product and facility registrations as needed.
  • Leads close collaboration with internal stakeholders and supports multiple projects.
  • Support regulatory inspections including facility preparedness.
  • Partners with internal and external stakeholders (e.g., regions, Health authorities) to align on an optimized regulatory strategy in order to achieve business objectives.
  • Manage and maintain a suitably resourced group with appropriately qualified personnel within budget.
  • Ensures awareness of and compliance with global regulatory requirements and adherence to internal policies and processes.
  • Ensure continual Quality System compliance by adherence to established documentation compliance to FDA QSRs, ISO 13485, and evolving requirements.
  • Participate in Business Continuity exercises and ensure templates are completed for all critical areas of the regulatory department.
  • Identifies and executes non-project related "regulatory excellence" activities.
  • In a timely manner, provides solutions to a range of regulatory issues and has the freedom to act independently to execute.
  • Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.
  • Demonstrated ability to lead and work effectively with multiple stakeholders.
  • Ensures timely, clear communications to external and internal stakeholders on project status and issues.
  • Strong writing skills in the form of high quality regulatory submission documents.
  • Demonstrated good organizational and time management skills, including the ability to work on multiple projects and adhere to timelines.
  • Meets individual goals as defined in the annual objectives.
  • Ability to support the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks.
  • Ability to excel in a matrixed environment and influence internal partners to achieve desired business outcomes.
  • Committed to drive efficiency while maintaining quality.
  • Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.
  • Engages stakeholders to co-create value, influence, align and lead internal and/or external stakeholders.

Key competencies

  • BS in an Engineering or Science discipline
  • Minimum: 5 years' experience in a Medical Device or related field having comparable technology and regulatory requirements.
  • Preferred: Over 5 years experience in a similar role in a highly regulated environment.

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

Ailis Dwyer
Ailis Dwyer
  • Consultant | Engineering Recruitment
  • 353 (0) 21 2300300
  • adwyer@morganmckinley.com