Boston Scientific Regional Regulatory Affairs Manager 

Turkey, Istanbul 

472252534

Bucharest-Romania; Lebanon-Beirut; South Africa-Johannesburg; Turkey-Istanbul

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 ;

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.