Authorised Representative Medical Devices

About Thermo Fisher Scientific:
At Thermo Fisher Scientific, each one of our 90, extraordinary minds have a unique story to. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.When youre part of Thermo Fisher Scientific, youll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best.Thermo Fisher Scientific provides industry leading pharma services solutions for drug development, clinical trial logistics and commercial manufacturing to customers of all sizes through our Patheon brand.Location/Division:
Thermo Fisher Scientific, Clinical Trials Division, Centurion, Gauteng, South AfricaReports To:
General Manager South Africa,Position Objective:
The Authorised Representative will hold responsibility of the end to end regulatory compliance process for Medical Devices and IVDs, the fulfilment of licencing requirements, classification of devices and the maintenance of import and export licences in South Africa and Sub-Saharan Africa.The holder of this position is independent in carrying out assigned tasks and with supervision plan, advise strategically and direct the business to enable growth, improve quality, customer experience, while developing organizational capability.What will you do-Holds responsibilities as the Management Representative for Fisher Clinical Services South Africas Medical Devices and IVDs system and ensures the systems are run and maintained efficiently in accordance to the relevant standards.Perform due diligence on new clinical trial study products and additions to the licence for registrations as per countries Health Authority HA requirements, within allocated timeframe.Timeous medical device registration or notification to the South African Health Products Regulatory Authority SAHPRA, up-to
- medical device file management, compliance and meeting of deadlines set.Lead as SME for Medical Devices and provide mentorship to team members on the content of the clinical study material and provide guidance on handling requirements or special product requirements as needed.Act as firstfor customer inquiries and complaints including diagnosing and troubleshooting problems, engaging other parties to resolve problems in a detailed and timely manner,and arrange/ensure follow upAssist internal business functions with reviews for clinical study protocols to assess supporting documentation required for product imports into various countries.Establish and maintain knowledge of regulatory requirements within South Africa and the Sub-Saharan Africa to ensure the business is up to with changes to regulations, laws and guidelines published.Maintain, review and update standard operating procedures linked to all relevant Regulatory Activities.Drive Best Practices, Innovate, document, improve work methods, standardize work practices, train, measure, and analyze key performance indicators to improve processes and improve customers experience.Responsibility for management of non-conformances deviations, complaints and quality investigations and related corrective and preventive actions through to resolution.Oversight of the ISO13485 certification process.Conduct all duties in compliance with GMP, ISO13485, ISO9001, GCP and other applicable regulatory requirements as identified.Lead all aspects of any recalls involving devices.How will you get here
2016 implementation, certification and upkeepExperience working with Health Authorities and Relevant Governmental Departments.Knowledge, Skills, AbilitiesA hands-on individual who can work independently with ability to multi-task, and lead/triage priorities.Assist in managing relationships with the Regulatory Authority.Good awareness of Medical Device, regulatory changes.Strong interpersonal skills and the ability to connect with and positively influence leadership and all levels of the organizationEfficient in software packages Microsoft officeThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 90, colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.