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Regulatory Affairs Subject Matter Expert II

Your role:  Provide regulatory support to the Cork manufacturing site product portfolio of Medical and IVD Devices products and provide subject matter expertise support for strategic projects and supporting of other Medical device manufacturing sites within EU as required.

  • Supporting the implementation global product registration and listing activities. Responsible for required regulatory submissions and product registrations/licensing for new products with either directly (for example in EU, US and Canada) or indirectly working with regional regulatory groups and or third-party representatives.
  • Support the implementation of strategic regulatory projects and initiatives including transition project to new regulatory requirements i.e. EU medical device and IVD regulations and new product development projects.
  • Support and implementation of any required regulatory re-certification or annual re-listings, updates and reports for regulated products.
  • Responsible for the review of change controls relating to regulated products and liaising with regional regulatory organizations to ensure any required regulatory change notifications/reporting or new submissions are carried out.
  • Responsible for the review of complaints and participating in risk assessments to determine regulatory vigilance requirements. 
  • Responsible for authority vigilance reporting either directly or liaising with regional regulatory groups or third-party representatives to facilitate vigilance reporting.
  • Responsible for regulatory review of document changes, deviations and printed materials as required to ensure all necessary regulatory requirements are met.
  • Act as liaison and correspondent between site and regulatory authorities such as EU Notified Bodies, US FDA, Health Canada etc.
  • Assemble and maintain technical files, device master records and other regulatory documentation to ensure current, and changes recorded. 
  • Review of updated standards and regulations, carry out documented review, ensuring any necessary updates are made and disseminating information throughout the site. 
  • Support preparation of and participate in any regulatory audits by regulatory authorities. 
  • Support preparation of and participate in any customer audits which require regulatory input. 
  • Responsible for answering customer (internal & external) regulatory requests or enquiries. 

 

Who you are:

  • A regulatory affair professional with experience working within the medical/IVD device industry.
  • Undergraduate Degree in a quality or science/engineering related discipline.
  • Good working knowledge of Medical device/IVD regulations within EU and NA, working knowledge of global medical device/IVD regulations.
  • Motivated, meticulous individual with excellent organisational, communications and technical writing skills.
  • Proven track record of organising work-load and activities to meet required deadlines.

 

Job Requisition ID:  198043
Location:  Carrigtwohill
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


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