Job Opportunity: Regulatory and Quality Affairs Specialist (RA/QA specialist)
||Medical & Healthcare
Regulatory and Quality Affairs Specialist (RA/QA specialist)
Responsible for all regulatory affairs activities worldwide. Assures regulatory submission compliance for submissions.
Maintains understanding and compliance requirements of regulatory affairs affecting company operations and products.
Generates and manages submission documents for new products or changes to existing regulatory submissions.
Responsible for designing, implementing, and maintaining an effective quality system.
Reports the performance of the quality system to relevant authorities and Company Management as required.
Director of clinical and regulatory affairs
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Prepare international regulatory strategies, submissions, registration and documentation
Perform coordination and preparation of documents packages for regulatory submissions from all areas of the company (collaborate with R&D, Engineering and other departments as needed)
Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
Provide regulatory guidance for product’s requirements and changes
Maintain Medical Device operations licenses for the relevant countries
Support and participate in internal/external audits and inspections and provide post-audit follow-up information, as requested
Recommend changes for labelling, manufacturing, marketing and clinical protocols for regulatory compliance
Evaluate current and new products for compliance with applicable regulations
Compile and maintain regulatory documentation databases
Analyze product complaints and make recommendations regarding their reportability.
Maintain current knowledge base, Identify, and interpret regulatory rules/guidance/ standards and ensure that they are communicated through corporate policies, procedures, work instructions.
Prepare or maintain technical files as necessary to obtain and sustain product approval.
Review adverse device effects and file all related reports in accordance with regulatory agency guidelines.
Writing comprehensible, user-friendly, clear product information leaflets and labels
Maintain all aspects of the quality system and its implementation throughout the organization
Initiate & maintain RA/QA related SOP
Plan, perform and oversee inspection and testing of products to ensure the quality deliverable
Detect coaching needs and take actions in accordance with these needs to ensure compliance with quality standards
Oversee risk management procedures
2+ years’ experience as a RA/QA specialist.
Extensive knowledge & experience of international medical device regulations and guidelines
Certification, such as Quality Engineer, Quality Auditor, Six Sigma, or Quality Improvement Associate, is preferred
Excellent analytical abilities
Full working proficiency in English
Excellent communication skills, both verbal and written
Able to write reports and business correspondence.
Proficient in Microsoft Office including Excel, PowerPoint and MS Project.
Possesses and applies problem-solving skills.
Able to work with details and complete assignments with minimal supervision.
Highly motivated and goal oriented.
Very high communication, presentation and customer-service skills.
Able to negotiate and build relationships at all levels.
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