Compliance Manager - Diagnostic Equipment

Recruiter:

Prostaff Holdings

Job Ref:

PS009661/CA

Date posted:

Wednesday, June 22, 2022

Location:

Johannesburg, South Africa

Salary:

Monthly

SUMMARY:
A well-established company requires the above to build and maintain solid functional systems and capacity for an effective risk-based compliance programme congruent with the dynamic and evolving regulatory, quality, health, and safety requirements of the environments the company operates in with regards to scientific diagnostic equipment.

JOB DESCRIPTION:

Minimum requirements for the role:

A qualification relating to Quality Management System (preferably ISO 13485) is essential. Project Management Qualification would be advantageous.
Must have experience having worked as a Compliance Manager with a proven ability in medical devices / IVD industry at management level.
Must have experience in dealing with SAHPRA and other regulatory bodies.
Experience with quality management systems (ISO 13485, 9001 and other standards).
Experience with internal and external quality management system audits (ISO 13485, 9001 and other standards).
In-depth knowledge and application of relevant legislation is preferred.
The successful candidate must have the ability to manage multiple projects and develop, guide and direct liaison and collaboration between various stakeholders.

The successful candidate will be responsible for:

Building and maintaining solid functional systems and capacity for an effective risk-based compliance programme congruent with the dynamic and evolving regulatory, quality, health, and safety requirements of the environments the company operates in with regards to high tech scientific diagnostic equipment.
Driving the establishment of strategies and implementation thereof to ensure quality and regulatory methodologies with ethical marketing and business practices, is suitably built and deployed in its operations and legal obligations across all sites.
Providing leadership and technical expertise to create and maintain a team of competent, effective, efficient, and committed resources.
Developing and communicating robust strategies through regulatory landscape knowledge.
Controlling and maintaining all applicable licencing and certifications of establishment and sites, products registration status and technical product files in line with current and applicable country requirements.
Directing medical devices and IVD regulatory submissions strategies to ensure timely new product registrations and post registration variations/amendments in South Africa and other African countries.
Devising strategic plans, objectives, project timelines, standards, policies, procedures for successful implementation and integration of all phases of the ISO 13485 quality management system leading to and maintaining certification.
Establishing RAQA information management systems and databases to optimally record, track and monitor tasks.
Reviewing, analysing and presenting periodic reports on compliance metrics to determine requirements for increasing quality, regulatory and safety compliance and prepare recommendations on findings for management and executive evaluation.
Leading site preparation and management of internal and external audits to ensure compliance with regulatory standards and best practices and established corporate procedures and requirements.

Salary package, including benefits, is highly negotiable depending on experience gained.

NB! This job is now closed. You can apply for other jobs by uploading your CV.

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