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Brian Christensen
Life Science

+353 (0)1 685 47 47
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Regulatory Affairs & Quality Manager

Reference:AVCK-566657 Location: Galway
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs Manager

Regulatory Affairs & Quality Manager

Our client is a start-up medical device company based in Galway. They are seeking a highly experienced Quality and Regulatory affairs manager be responsible for the management, development and improvement of quality system as well as the completion of all global product certifications. The successful candidate will be a key player in transfer of new products from development to commercialisation and post launch.

The role includes the following responsibilities and skill sets:
• Develop, administer and maintain the Quality System
• Monitor the suitability and effectiveness of the Quality System and assure compliance with
current US and international regulations and ISO standards.
• Continuous improvement of the system to meet the evolving expectations of customers,
business partners and regulators
• Preparation for and completion of market clearance applications (PMA/510k) to the FDA for
new products
• Define the Quality Assurance and Regulatory Affairs Budget Proposal and assure constant
monitoring of it.
• Manage and lead the activities of Quality Team
• Ensure the Quality System supports the corporate quality policy and quality objectives
• Keep abreast of changes in domestic and international Quality Systems regulations and
guidelines, and advise Key staff of compliance/noncompliance with current international regulations,
policies and EC directives
• Manage Quality System audit processes
• Manage the communication with the regulatory authorities
• Advise Key staff of compliance/non-compliance with current international regulations, policies
and EC directives.
• Manage the Validation function
• Support the development and implementation of EHS projects, risk assessment, procedures
and instructions and to oversight on the correct application, including self-audits in the area of
responsibility (e.g. PPE) Availability to participate in limited travelling to meet with customers to conduct scheduled reviews.

Skills & Experience Required:
•Drives Accountability and Models Ethical Behaviour
•Knowledge of regulatory standards and design control systems desirable but not essential
•Degree level 8 in Engineering/Science or related discipline with 7-10 years relevant experience
additional relevant qualifications may be advantageous Qualification in a quality assurance role in the pharmaceutical, healthcare or medical device/lVD sector and in a FDA regulated environment is essential with no less than 3 years’ experience working in a Senior Management role
Successful preparation for and completion of premarket approval applications and 510k to the FDA.
•Successful preparation for and completion of an FDA Audit
•Intensive knowledge of quality management systems and current International and European regulations/standards with respect to medical devices.
•Successful implementation of a Quality IT System implementation is essential
•Knowledge of US and international medical device Quality System regulations and ISO standards
•Highly developed written and verbal communication skills
•Independent problem-solving skills
•Proficient in data collection, analysis and presentation
•Experince and knowledge in design, verification and process validation techniques
•Experience and knowledge in designing, verifying, optimizing the processes within the organization to guarantee the compliance
•Experience with statistical techniques (DOE, Six Sigma)
•Manages time consistently with a multi-tasking approach
•Dynamic team player and leader and can work effectively and proactively on cross-functional teams.
•Proven influencer and exhibit skills in technical initiatives
•Strong communication and presentation skills are desirable

Clodagh Nerney | Tel: +353 (0) 1 507 9254