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REGULATORY & COMPLIANCE MANAGER - 361302
REGULATORY & COMPLIANCE MANAGER
Biological / Scientific / Pharmaceutical / Medical Research
Wage / Salary:
R - Market Related - P/M (Per Month)
Major supplier of medical equipment and products is looking for a Regulatory & Compliance Manager, based in Gauteng. The ideal candidate must have a degree and regulatory & compliance experience in the pharmaceutical or medical supply field. Manage audits, regulatory agency inspections or product recalls. Manage relevant regulations, proposed and final rules, affairs, policies etc. Travel to various sites, clients, distributors etc. is required - Nationally and Southern Africa.
Duties & Responsibilities
Provide responses to regulatory agencies regarding product information or issues.
Train staff in regulatory policies or procedures.
Coordinate internal discoveries and depositions with legal department staff.
Maintain current knowledge of relevant regulations, including proposed and final rules.
Manage activities such as audits, regulatory agency inspections, or product recalls.
Participate in the development or implementation of clinical trial protocols.
Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
Formulate or implement regulatory affairs policies and procedures
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
Communicate regulatory information to multiple departments
Develop regulatory strategies and implementation plans
Implement or monitor complaint processing systems
Investigate product complaints
Monitor emerging trends regarding industry
Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
Represent organisations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
Review all regulatory agency submission materials.
Review materials such as marketing literature or user manuals
Contribute to the development or implementation of business unit strategic and operating plans.
Establish procedures or systems for publishing document submissions
Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions.
Required to visit and perform audits at National and Southern African clients, suppliers and distributors
Desired Experience & Qualification
BA/B Com degree
Regulatory & compliance Legal knowledge
3- 5 years’ experience
Valid Driver’s license
Medical/Pharmaceutical industry knowledge
A Consultant will be in touch if you are shortlisted for the position. Please consider your application unsuccessful should you not have been contacted within 2 weeks. We will keep your CV on our database and contact you should you match the criteria of any other vacancies.