Regulatory Affairs Manager - South Africa - Boston Scientific Corporation - Johannesburg

Work mode: Hybrid Onsite Location(s): Johannesburg, South Africa Additional Locations: South Africa-Johannesburg; Bucharest-Romania; Lebanon-Beirut; Turkey-Istanbul Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. The Regulatory Affairs (RA) manager is a strategic partner to the business that supports, delivers and sustains regulatory solutions for patients & customers. This role will report to the GEM Regulatory Lead and will support the overall vision and goals of the GEM Regulatory organization as well as the GEM region. Key Responsibilities Lead/Manage and develop a team of Regulatory specialists and principals. As team manager, ensures that team members receive appropriate training, coaching and development plan Support the team to prioritize and plan on product registrations/renewals/variations candence in line with the business strategy and report out on progress to the business and management team Ensure Postmarket compliance as per local requirements. Responsible for monitoring & influencing new regulatory requirements and ensuring timely internal communication & implementation: Actively contributes to local medical device industry groups and establishes and implements plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education Provide management and business team with regular updates related to these new requirements and work with appropriate team to ensure they are implemented Partner with regional and global cross-functional teams to provide regulatory input to projects and business strategy Support internal and external audits as needed 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. 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 BSC Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality System. Requirements 7-10 Years of minimum experience in a multinational environment in the area of regulatory affairs Experience in Medical Devices regulations and people management is a must Excellent knowledge of the EU and FDA regulations with previous experience in preparing and submitting technical files to EU and/or FDA Strong time management, coordination, and communication skills, capable of independently execute and oversee regulatory tasks Demonstrating a proactive approach to work within a dynamic regulatory environment. Your English language skills enable you to collaborate with colleagues as well as internal and external stakeholders on a global basis. Additional language skills are an advantage. Job Scope and Leveling Guidelines Knowledge A seasoned, experienced professional with wide-ranging experience and expertise in a specialized field. Applies comprehensive knowledge of a particular field 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 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. Mentoring Participates in the development of others by facilitating training and providing feedback and guidance. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Please contact your local EH&S department for more information on physical requirements. Requisition ID: 578638 As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen. So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you Job Segment: Regulatory Affairs, Compliance, Medical Device, Law, Manager, Legal, Healthcare, Management Apply Now

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Regulatory Affairs Manager - South Africa - Johannesburg

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