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Colin Clare
Life Science

+353870608656
[email protected]
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Details

Regulatory Affairs Associate


Reference:CCL (AHPD-441806) Location: Cork
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Nurse Associate, Regulatory Affairs

Job Title: Regulatory Affairs Associate
Location: AventaMed Rubicon Centre, Bishopstown, Cork

Benefits:
Competitive Salary, Bonus, Pension, Healthcare + Excellent opportunity to develop your experience and career in an exciting company.

Company:
MyclienthaverecentlybeenacquiredbyKarlStorzandhavedevelopedabreakthroughsingle-usemedicaldevice,Solo+TTDthataddressespainpointsofthecurrenttreatmentofthesurgicaltympanostomy,aprocedurethatdrainsouttheexcessfluidbuiltupintheear.Thesurgical tympanostomyisthemostcommonproceduredoneonchildren.

Overview:
In this role you will be responsible for regulatory submissions worldwide, annual reporting to the notified body and competent authorities, and maintaining compliance to standards and regulations. You must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry.

Responsibilities:

  • Support day-to-day regulatory activities as well as handling multiple projects related to regulatory compliance enhancements.
  • Assist in the implementation of MDSAP within the organisation.
  • Support the team to obtain / retain country-specific regulatory registrations on a global basis.
  • Work with the Commercial Team / Distributors, to ensure country specific registration activities are understood and appropriately addressed.
  • Work closely with interdisciplinary team members to ensure the effectiveness of the QMS to regulations.
  • Work closely with QA for internal and external audits, including notified body audits as required.
  • Support the wider team to ensuring product manufacture and testing meets the requirements of both CE mark and FDA submissions.
  • Work with the organisation’s suppliers to ensure the products’ process validations and risk management files are to the standard of regulatory submissions.
  • Provide strategic regulatory insight to team members regarding product development plans
  • Maintain the day-to-day activities of Post Market Surveillance, including, but not limited to:
    • Working collaboratively with KARL STORZ
    • Logging customer complaints and adverse events
    • Coordinating investigations between complainants and contract manufacturing sites and address initiatives to test, change and improve the products as required
    • Regulatory trending and reporting activities as required
  • Monitor global regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance.
  • Evaluating manufacturing and labelling changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations
  • Maintaining awareness of global regulatory legislation and assess its impact on business and product development programs
  • Keep abreast of changes in domestic and international regulations and guidelines and advise key staff of compliance/non-compliance with current international regulations, policies and EC directives.
  • Support the team with CE mark submissions, significant change notifications and Notified Body interactions.
  • Support the team with the preparation of international regulatory filings, including 510(k) submissions and subsequent FDA correspondence.
  • Carry out other regulatory related duties as required.
Education
  • Bachelor’s degree in Engineering or Science with a minimum of 3 years of regulatory experience in the medical device industry.
  • Regulatory certifications in EU MDR and US FDA desirable.
  • Thorough understanding and knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, US 21 CRF 820 and supporting standards.
  • Proven track record with the ability to successfully manage projects to deadlines
  • Experience working directly with regulatory agencies

Does this sound like your next career move? To apply, forward your application to the link provided or contact me on 087 0608656 OR [email protected]