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.

Similar jobs you might be interested in:

Cost Compliance Manager (Pretoria)
Location: Pretoria
Salary: NEGOTIABLE
Responsible for ensuring that all spending and expenses align with the organization''''''''s established budget and cost control guidelines
3 days ago

Risk & Compliance Manager
Location: Sandton
Salary:
5 days ago

Ops and Compliance Manager
Location: Johannesburg
Salary: Annually
Are you a proactive professional with a knack for regulatory compliance and operational excellence?
7 days ago

Compliance Supervisory Framework Manager
Location: Pretoria
Salary:
Managed Talent Solutions' client, a major player in the Financial Services industry seeks a highly skilled and dynamic professional to join their Insurers Supervision Department as a compliance Supervisory Framework manager. This role is critical in supporting the general management of the department, coordinating key supervisory projects, and providing technical expertise to enhance and mai...
10 days ago

SHE and Compliance Manager
Location: Brits, Gauteng
Salary: TBA
Brits, Northwest Province
81 days ago

Technical Workshop Manager
Location: Akasia
Salary:
10 days ago

Remuneration & Benefits Manager
Location: Johannesburg
Salary: R negotiable
Remuneration & Benefits manager
Today

Junior Finance Manager
Location: Midrand
Salary:
Are you a driven and detail-oriented finance professional ready to take on new challenges? We are looking for a Junior Finance manager to join our dynamic team and contribute to both specific business units and group finance activities.In this role, you’ll work in a fast-paced environment, handling critical financial tasks while ensuring compliance, accuracy, and efficiency.
Today

Operations Controller
Location: Brakpan
Salary: 30000
Our client in Gauteng is looking for an Operations Controller to join their team
Today

Fleet Operations Manager
Location: Kempton Park
Salary: R50k - 55k per month
Fleet Operations manager
Today

Compliance Manager - Diagnostic Equipment

Similar jobs you might be interested in:

Create a free job alert for Compliance Manager - Diagnostic Equipment in Johannesburg

Jobseekers

Recruiter

General