Principal Regulatory affairs Specialist
€75000 - €85000 per annum
Principle Regulatory affairs Specialist
Our Client a leading Medical Device Company in Galway are currently looking for a Principal Regulatory Affairs Specialist to join their team.
This is a highly collaborative position working closely with all functions at all levels to plan, lead and manage the successful achievement of the Regulatory Affair's project deliverables across the product development process. You will report to the Director of Regulatory Affairs.
- Lead compilation of international regulatory submissions for company products under development. Manage regulatory submission timelines, identify risks, and appropriate mitigations.
- Review the data intended for submission in international regulatory applications. Identify gaps and make recommendations.
- Participate in risk management activities for designated projects.
- Provide regulatory input during design control process to development projects.
- Support CE Mark maintenance and substantial change submissions to notified body.
- Define and capture the regulatory strategy for the development project(s).
- Co-ordinate and support regulatory reviews and meetings with EU Notified Bodies, Competent Authorities, FDA, PMDA and NMPA.
- Review and contribute to regulatory aspects of change control, non-conforming process, labelling changes etc.
- Support routine safety reporting activities for clinical investigations.
- Support vigilance reporting activities in the company
- Support post market surveillance reporting, annual progress reports.
- Review and contribute to clinical evaluation reporting activities.
- Work within the quality system and ensure that the quality policy and company systems and procedures are complied with in line with the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, MDR 2017/745, FDA Quality System Regulations 21 CFR Part 820, ISO 14971, and Japanese Ministerial Ordinance #169.
- Work towards achieving compliance to the Medical Device Regulation 2017/745.
The Ideal Candidate:
- Degree level qualification in engineering or a strongly related field.
- A minimum of 5 years' relevant regulatory experience in a senior regulatory role in the medical device or pharmaceutical industry, ideally with Class IIb and Class III medical devices.
- Technical competency of ISO13485:2016, MDD 93/42/EEC, MDR 2017/745, and the FDA QSRs is a prerequisite.
- Good communication and organizational skills, computer literacy and the ability to present reports neatly and accurately is essential.
For more information on the Principal Regulatory affairs role please contact Orla Crowley 0830286256
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This position was pPosted on 23 May 2021