Specialist Principal Regulatory Affairs

The role is critical in supporting all regulatory activities in South Africa and meeting aligned objectives. Develops and manages a strong relationship with the regulatory bodies (covering product notifications, materiovigilance, field actions and any other specific program). Provides regulatory support and expertise to the organization as required. Manages the impact of the regional and national regulations to the business. Supports lobbying activities.

Key Responsibilities

Reporting into the Senior MEA Manager
Regulatory: Prioritizes and plan on product registrations for his/her respective
product lines; Prepares, coordinates and submit regulatory applications to the local health authority, other regulatory authorities or distributors based on local requirements and applicable laws; Secures regulatory approvals; maintains approvals by submitting on time renewals and variations; Monitors local as well as regional regulatory environment and providing updates; Prepares and executes clinical study notifications to regulatory bodies where applicable; Communicates with regulatory bodies on field corrective actions, vigilance etc.
Business: Participates Assist in strategic planning for the region providing regulatory input; Maintains an active knowledge of the status of pending approvals and registrations; Upon requires provides regulatory related information to business country heads, sales managers and customer services; Participates or support in regional/country business reviews and provides regulatory input; Supports local customer services and tender department in terms of providing regulatory documents, translations, solving regulatory issues; Provides literature and advertising review for locally produced promotional materials where applicable; Raises non-compliance issues and business exposures to business country heads and Director of RA for EMEA; Acts as a link to Quality team.
Influencing: Builds trusted relationship with regulatory bodies in the region; Participates in relevant working groups of industry associations; Takes part in lobbying activities either as representative or via industry association.

Job Description

Quality System Requirements
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Collaborate with in-house teams to successfully launch new and current technologies in key market and support market access.
For those individuals that supervise others, the following statements are applicable:
Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy.
Establishes and promotes a work environment that supports the Quality Policy and Quality System.


Knowledge

Job Scope and Leveling Guidelines
A seasoned, experienced regulatory professional with preferable medical device or pharmaceutical experience and associated regulatory expertise (+5 years minimum).
Solid understanding of South African and other African medical device regulations and applicable laws..
Demonstrates a working knowledge of advocacy practices.
Applies comprehensive knowledge to resolve complex issues in creative ways. Full knowledge of other related disciplines. Uses in-depth knowledge of business unit functions and cross group dependencies/relationships. Is recognized as an expert in the work group.
Problem Solving
Develops solutions to diverse business problems of high complexity which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Has specialized knowledge of various alternatives and their impact on the business. Challenges are frequently unique and solutions may serve as precedent for future decisions.
Planning and Organization
Plans and organizes project assignments of substantial variety and complexity. Initiates or maintains schedule for projects and project milestones.
Discretion/Latitude; Supervision Received; Decision Making
Works without appreciable direction. Works independently on highly specialized projects with long range objectives. Exercises considerable latitude in determining objectives of

Job Description

assignment. Selects methods and techniques to lead a project to completion. Develops departmental policies and procedures, new techniques and standards. Work is reviewed from a relatively long- term perspective, for desired results.
Business Relationships and Project Management
Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units. May lead specialized project teams which have a broad impact on the company utilizing cross-functional resources. Provides leadership to business units.
Impact

Guides the successful completion of major programs and often functions in a project leadership role. Effects of decisions are long-lasting and influence the future course of the organization. Errors in judgement or failure to achieve results would result in the expenditure of large amounts of company resources.

Liaison

Serves as a consultant to management and special external spokesperson for the organization on major matters pertaining to its policies, projects, or objectives. Uses diplomacy and tact to diffuse high tension situations, particularly with senior level internal and external contacts. Occasionally escalates the most serious issues to manager.