Our client, a leader in the aspect of research, design, development and manufacture of biomaterial solutions for medical implant products, are actively looking to recruit for an experienced RA and QA Manager for the plant in Galway.
This is a new role which has arisen within the organisation due to new business requirements. The successful candidate will have experience in dealing with Design Assurance and Regulatory Affairs for vascular products. This role will be reporting directly into the Chief Executive Officer and is responsible for maintaining and ensuring that the Company?s Quality Management System complies with FDA, ISO 13485 and international medical device regulatory standards.
- To act as the point of contact for all regulatory communication in the company, including incident reports, audits, registrations, etc.
- Establish, manage and maintain compliance with FDA QSR, including establishment registration, new product submissions, CAPA System.
- Establish, manage and maintain compliance with MDD 93/42/EEC directive, including CE Mark applications via Technical Files.
- Manage and maintain compliance to ISO13485 requirements.
- Responsible for responding and reporting incidents to all approved markets.
- Responsible for the Customer Complaint System.
- Provide direct supervision, coaching and mentoring to engineers. This includes the areas of priorities, work directions objectives settings developmental opportunities and performance management work directions, objectives settings, developmental opportunities and performance management.
- Manage the Quality Assurance and Regulatory department.
- Develop annual goals and objectives for Design Assurance group ensuring they align with Cardiovascular Quality and CSH organizations.
- Responsible for continuous improvement activities as determined in goals and objectives
- Establish department goals, budgets, measurement and metric systems in line with business objectives to ensure quality standards are achieved and thus ensure that new product development projects are effectively managed.
- Apply clinical knowledge of product use to ensure appropriate quality and design decisions are made and to support the development of bench simulations/tests to evaluate new product designs
- Ensure all product evaluations from prototype testing to design verification are managed to the highest quality standards in compliance with corporate, regulatory and cGMP requirements.
- Provide technical support and critical review to product development projects in problem solving and failure investigation and as required in the investigation of field returns.
- Manage the preparation and submission of all necessary submissions (experience in PMA, 510(k) for the US, MDD requirements in Europe, and various global submission types is desirable)
- Ensure compliance with current/emerging guidelines and regulations, and ensure appropriate policies and procedures are implemented.
- Analyse regulatory guidance documents, anticipate the impact of changing regulations on development plans and regulatory strategies.
Education, Experience and skills
- Honors Bachelor?s Degree/Masters in a relevant scientific or engineering discipline.
- Minimum of 10plus years? experience in Quality Assurance and Regulatory affairs within the medical devices field of use.
- Quality systems, quality operations knowledge & design assurance experience
- The ability to identify regulatory problems of diverse scope and purpose solutions through collaboration and coordination with others.
- Experience with FDA, Notified Bodies and/or International regulatory authorities is an advantage.
- Strong verbal and written communication and influencing skills with good relationship building skills with coaching skills
- Strong decision making and judgment
- Change Management, excellent problem solving skills and results orientation.
For further information on this Regulatory and QA Manager job in Galway please contact Nicola O?Connell on 091730022 / Nicola@hero.ie
Check out all our open jobs on our HERO Recruitment website ? www.hero.ie
Please Note: HERO Recruitment will not forward your details to any company without your prior approval