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Senior Regulatory Affairs Specialist

Title : Senior Regulatory Affairs Specialist profile
Sector : Manufacturing & Production
Location : Offaly
Reference : CW120559
Contact : Louise Mulligan
Office : Mayo
Tel : 094 900 3979
Email : lmulligan@careerwise.ie

Job Description

A Senior Regulatory Affairs Specialist is required by CareerWise Recruitment for our Midlands based client. There is a huge potential for growth within this Medical Device Company.

Role of this position

  • Supports the manufacturing of Class II (US), IIb and III (EU) electrical/mechanical medical devices and related components and accessories.
  • Reviews and approves all related change orders and performs the necessary regulatory assessments, working with a larger regulatory team to determine pre-approval requirements.
  • Responsible for the development and maintenance of EU product files including Class III design dossiers and Class IIb, IIa and Is technical files which facilitates timely regulatory approvals.
  • Represents regulatory affairs on project/product development teams and will be responsible for the development and implementation of global regulatory strategies based on US FDA regulations, European Medical Device Directive, External Standards, and other international regulations.
  • Perform analysis of complaints to determine if the incident is reportable under EU MDD/MDV requirements and completes MDV documentation for on-time filing.
  • Assists with international registration requests to support international growth.
  • Works with their manager to prioritize regulatory workload based on compliance and business objectives.
  • Works with their manager to make regulatory decisions that allow the company to achieve its goals while maintaining regulatory compliance.

JOB REQUIREMENTS

  • This individual must have at minimum a Bachelor’s degree (or equivalent international degree) with 3-5 years of experience or equivalent combination of education and experience in supporting manufacturing of medical devices.
  • This individual must have proven skills in the developing CE registrations and US PMA/510(k) Premarket Notification.
  • This individual must possess knowledge of US FDA regulations, ISO Standards, and European Medical Device Directive (MDD). This individual must have experience working with US FDA, European Notified Bodies and Competent Authorities and other regulatory agencies.

Please call Louise Mulligan today for further information on 094 900 3979 or email: lmulligan@careerwise.ie CareerWise Recruitment -

IN SEARCH OF EXCELLENCE
CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Mayo ,Cork, Shannon, Galway and Dublin

 

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Careerwise Recruitment



Senior Regulatory Affairs Specialist

Title : Senior Regulatory Affairs Specialist profile
Sector : Manufacturing & Production
Location : Offaly
Reference : CW120559
Contact : Louise Mulligan
Office : Mayo
Tel : 094 900 3979
Email : lmulligan@careerwise.ie

Job Description

A Senior Regulatory Affairs Specialist is required by CareerWise Recruitment for our Midlands based client. There is a huge potential for growth within this Medical Device Company.

Role of this position

  • Supports the manufacturing of Class II (US), IIb and III (EU) electrical/mechanical medical devices and related components and accessories.
  • Reviews and approves all related change orders and performs the necessary regulatory assessments, working with a larger regulatory team to determine pre-approval requirements.
  • Responsible for the development and maintenance of EU product files including Class III design dossiers and Class IIb, IIa and Is technical files which facilitates timely regulatory approvals.
  • Represents regulatory affairs on project/product development teams and will be responsible for the development and implementation of global regulatory strategies based on US FDA regulations, European Medical Device Directive, External Standards, and other international regulations.
  • Perform analysis of complaints to determine if the incident is reportable under EU MDD/MDV requirements and completes MDV documentation for on-time filing.
  • Assists with international registration requests to support international growth.
  • Works with their manager to prioritize regulatory workload based on compliance and business objectives.
  • Works with their manager to make regulatory decisions that allow the company to achieve its goals while maintaining regulatory compliance.

JOB REQUIREMENTS

  • This individual must have at minimum a Bachelor’s degree (or equivalent international degree) with 3-5 years of experience or equivalent combination of education and experience in supporting manufacturing of medical devices.
  • This individual must have proven skills in the developing CE registrations and US PMA/510(k) Premarket Notification.
  • This individual must possess knowledge of US FDA regulations, ISO Standards, and European Medical Device Directive (MDD). This individual must have experience working with US FDA, European Notified Bodies and Competent Authorities and other regulatory agencies.

Please call Louise Mulligan today for further information on 094 900 3979 or email: lmulligan@careerwise.ie CareerWise Recruitment -

IN SEARCH OF EXCELLENCE
CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Mayo ,Cork, Shannon, Galway and Dublin

 

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