Search Results: 12 vacancies
...Specific Role Requirements:
Healthcare
Healthcare (IHSS, Clinical Solutions): Working knowledge of ISO 9001, 13485, LSAS & MDD93/42/EEC.
Healthcare (Textile solutions) working knowledge of EN14065.
Knowledge and Skills:
Experience of managing a team,...
...Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
Participation in the new product introductions programmes to ensure that they are effectively introduced in...
...regulatory requirements.
Responsibility for assisting in implementing regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA 21CFR Part 820 as required and other jurisdictions as required.
Maintains an...
...requirements of International Standards: ISO 13485, the FDA Code of Federal Regulations 21 CFR Part 820, Medical Device Directives 93/42/EEC and 2007/47/EC and the Companies Medical Quality Management System.
Main Duties & Responsibilities
Build sub-assemblies and...
...medical device regulations for specific jurisdictions as assigned such as regulatory requirements in accordance with (EN)ISO13485, MDD 93/42/EEC and EUMDR 2017/745 and additional EMEA regulations (including the UK and Switzerland) as required, become proficient / knowledgeable in...
...experience is in the medical device manufacturing industry in a similar role.
Working knowledge of the Medical Device Directive (93/42/EEC) ISO13485 Quality System Standard ISO 14971 Risk Management and Canadian Regulation (CMDR)
Good communication skills both verbal and...
...medical device regulations.
Responsibility for implementing applicable regulatory requirements in accordance with ISO13485, MDD 93/42/EEC, EU Medical Device Regulation 2017/745 and FDA QSP 21CFR Part 820 as required.
Coordinates multiple projects at one time and...
...Co. Cork
Appropriate Assessment Screenings for Section 48 and 49 Consents
In accordance with:
Article 6(3) of Directive 92/43/EEC (the Habitats Directive); and
Regulations 42(1) and 42(2) of the European Communities (Birds and Natural Habitats) Regulations 2011...
Commission for Regulation of Utilities
Dublin
3 days ago
...Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
Participation in the new product introductions programmes to ensure that they are effectively introduced in...
Cpl Healthcare
Connacht
5 days ago
...Maintenance of the Quality Management System with all the clients’ processes in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
Deputizing for the Management Representative in their absence.
Provision of support to all departments to ensure...
Matrix Recruitment Group
Connacht
5 days ago
...Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485 & MDD 93/42/EEC.
Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the...
Matrix Recruitment Group
Connacht
5 days ago
...Documenting and establishing a Quality System which assures compliance with them requirements of I.S. EN ISO 13485, EC Directive (93/42/EEC), MDR (2017/745) and Abbott Corporate and International Quality Policies and Procedures.
Establishment of procedures and plans that...
Abbott Laboratories
Sligo, Co. Sligo
4 days ago
