Job Responsibilities
- Support CE Mark maintenance and substantial change submissions to notified body.
- Define and capture the regulatory strategy for the development project(s).
- Lead compilation of international regulatory submissions for company products under development.
- Review and contribute to regulatory aspects of change control, non-conforming process, labelling changes etc.
- Manage regulatory submission timelines, identify risks and appropriate mitigations.
- Review the data intended for submission in international regulatory applications. Identify gaps and make recommendations.
- Provide regulatory input during design control process to company development projects.
- Participate in risk management activities for designated projects.
- Co-ordinate and support regulatory reviews and meetings with EU Notified Bodies, Competent Authorities, FDA, PMDA and NMPA.
- Support routine safety reporting activities for clinical investigations.
- Support vigilance reporting activities in the company.
- Review and contribute to clinical evaluation reporting activities.
- Support post market surveillance reporting, annual progress reports.
- 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.
- 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.
Or call Megan Warr on 085 8019023 for a confidential conversation
