Quality Assurance & Regulatory Affairs Leader

Temporary position: 1year - possible extension to permanent role

The Quality Assurance & Regulatory Affairs Leader will support the development and of the local Quality Management System and manage Regulatory Affairs, support implementation of the Company Quality Standards into the local system, drive development of standard operating procedures. The Role will be responsible for various QA activities, such as maintenance and execution of Internal Quality Audit Program and driving process improvements, addressing CAPA.
Ensures effective communication and trainings are deployed throughout the Organization on Quality Management System elements. This position will report to Regional Quality function.

Management of Regulatory Affairs including but not limited to Regulatory Outreach on local and EU level, management of product portfolio and copy review.

QUALITY ASSURANCE:

• Ensures the maintenance of quality records, nonconformance, project outcomes, and that stakeholder input is filed in an accurate and timely manner.
• Management and Review of the change control process, tracks the approval process / action execution.
• Acts as Management Representative (Quality System Management Reviews)
• Management of CA/PA, contributes to the development of corrective action / preventive action plans and monitors implementation.
• Management of the nonconformance
• Reports on execution and closure of corrective and preventive actions, nonconformance, strong cooperation with CAPA, NC Owners.
• Performs GAP assessment evaluation against corporate standards and support process improvement implementation.
• Monitors and Leads investigations, recognizes trends and presents reports for assigned quality processes – Risk Assessment.
• Reviews reports on current quality systems and supports improvements in order to enhance quality.
• Execution of Internal Audits within Company, assures preparation for External Audits and Health Authorities Inspections and Corporate Quality Audits.
• Local Management of escalation process of Quality Compliance matters
• Monitors trends, identifies issues, recommends and implements appropriate actions.
• Develops implements and reviews Standard Operating Procedures, Work Instruction and other Quality Documentation.
• Quality oversight to Supplier Management process, assessment of suppliers based on Quality Assurance criteria, company quality policy, standards and local regulations
• Management of product complaints, post market surveillance & vigilance
• Cooperate with Customer Service on Quality of Service Complaints
• REGULATORY AFFAIRS:
• Management of product notification (Biocides and Medical Devices),
• Copy Review of promotional materials and labeling artwork (IFU & Label)
• Product Portfolio Management (including New Product Introduction),
• Environmental Controls in relation to Medical Devices & Biocides,
• Regulatory Outreach within local Competent Authorities, associations,
• Cooperation with RA Community at Legal Manufactures,

SKILLS:

• Quality Auditor Certification (Internal or Lead)
• Quality Management Systems ISO 9000 and/or ISO 13485,
• Risk Management,
• Problem solving skills (e.g. Root Cause Analysis, Failure Investigation)
• Understanding of Regulatory Requirements, Medical Device Directive & Medical Device act in Poland
• Fluent in English

COMPETENCIES:

• Pro-active
• Emotional Intelligence
• Discretion and confidentiality
• Multitasking
• Ability to communicate with others at all levels to successfully achieve outcomes
• Excellent inter-personal skills; ability to listen and understand
• Excellent, organizational skills and time management skills
• Embodies values, ethic and trust

• Employment in a well branded international company
• Unique experience
• Competitive salary and benefits
• Ethical work environment
• 1 year contract (replacement) with a possibility of a permanent role