• Head/Manager Regulatory Affairs & Compliance Colombo
  • Finder Recruitment in Colombo, , Sri Lanka
  • jobs
  • 1 week ago

jobs description

Job Duties
• Keep updated on relevant standards, regulations/laws, its revisions, current issues, and market intelligence.
• Liaise with certification bodies, notified bodies and other regulatory bodies for product / system certification before expiration.
• Achieve financial objectives by preparing an annual budget, optimizing expenditures, analyzing variances and initiating corrective actions.
• Identify training needs of team members and arrange necessary trainings to improve their performance.
• Ensure compliance to mandatory regulations & management systems adopted in factories in Sri Lanka. This include ISO 9001, 14001, 13485, 50001, 45001, CTPAT, SMETA, STeP, RCS or any other standards that are part of company’s management systems.
• Manage ISO 17025 accredited laboratory
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation or marketing of products.
• Ensure proper manufacturing and housekeeping practices and... maintain high level of safety and cleanliness in work place with Zero LTI.
• Alert the management timely on any possible non-compliances related to any relevant standards.
• Ensure zero production delays/ losses due to compliance issues.
• Ensure required compliance policies & procedures are developed, reviewed, implemented and adhered to by all the departments.
• Ensure all products are aligned to applicable current standards and regulations.
• Work with sales team on product extensions and product specifications.
• Update product information system data and ERP data.
• Ensure annual timely registration at FDA, UL and regulatory bodies.

• Male/ Female
• Age below 50
• A degree or Diploma (including Chemistry, physical science or polymer science as a subject) from a recognized university
• Diploma in Quality Management will be an added advantage
• Minimum of 6 Years of Experience in similar capacity
• Possesses strong leadership qualities, analytical skills, interpersonal & communication skills
• Must be savvy with ISO management systems standard, internal auditing, Medical device regulation and standards, PPE regulation and standards
Colombo Sri Lanka


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