Regulatory Affairs Manager

**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 standa