Regulatory Affairs Manager - South Africa

at  Boston Scientific Corporation

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.

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.

• 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