QA/RA Director
- Employer
- Thornshaw Recruitment
- Location
- Wicklow (County), Leinster (IE)
- Salary
- DOE
- Start date
- 10 May 2021
- Closing date
- 28 May 2021
View more
- Discipline
- Quality, QA / QC, Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Director/Executive
Job Details
QA/RA Director
On behalf of my client, I am recruiting for a QA/RA Director.
The successful candidate will be responsible for leading the RA/QA team within the organization, over 2 sites in Europe, to assure compliance to international quality and regulatory requirements for IVD. This role reports to the Executive Director.
Key Responsibilities:
- Development and implementation of a strong and effective RA/QA strategy.
- Product submissions/approvals, license renewals, periodic updates, and product company registrations to regulatory agencies (CE, US, China etc)
- Fulfil role of Management Representative of the Company Management System, and is the main point of contact with QMS certification/notified bodies, regulator, and Competent Authorities (in support of Vigilance reporting as required)
- Documented QMS.
- Lead team during external audit (MDSAP) as well as during authorities or customer inspection.
- Risk Management, Deviation & CAPA Management, Complaint Management, Post Market Surveillance and Quality auditing.
- Ensure that evolving international standards and regulations of interest are identified and anticipated.
- Will be the first contact person for all QA/RA matters.
- Collaborate with other members of management to develop new product and engineering designs and manufacturing and training methods.
- Achieve financial objectives by preparing the QA/RA budget, scheduling expenditures, analyzing variances, and initiating corrective actions.
- Contribute to team effort by accomplishing related results as needed.
- Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications, establishing personal networks, and participating in professional societies.
Qualifications/Experience:
- Advanced science degree with minimum 10 years’ experience, with IVD industrial experience.
- Strong RA and QA background for IVD medical devices.
- Knowledge of global regulatory standards required (EU, China, US) and international registration processes.
- Extensive experience implementing, interpreting, and providing guidance on domestic and international regulations for medical devices/ IVD.
- Comfortable with technical data, and to effectively present and respond to questions on global requirements and practices.
- Development of the members in the team to effectively execute the RA/QA activities.
- Knowledge of safety requirements and legal standards.
- Experience with QA measuring and testing equipment.
- Comfortable with technical data, and to effectively present and respond to questions on global requirements and practices.
- Development of the members in the team to effectively execute the RA/QA activities.
- Knowledge of safety requirements and legal standards.
- Experience with QA measuring and testing equipment.
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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