Abbott Diretor de Assuntos Regulatórios - Divisão Cardiovascular e Neuromodulação (CAHF) - São Paulo/SP in Sao Paulo, Brazil
Responsible for hiring and retaining a diverse, highly qualified staff and for providing career coaching, growth and personal development. Responsible for the development of staff: critiques, instructs, mentors, evaluates and coaches. Accountable for the performance of subordinates as well as the work output of managed subcontractors. Maintains a safe working environment and a strong customer focus. Models optimum leadership competencies to inspire an energized, empowered and accountable work force. Models ethical behavior, presents a favorable community image and actualizes Abbott principles and management values.
Set strategy and goals for and direct preparation of submissions for products to international regulatory agencies, and interfaces with agencies in order to obtain timely approval to produce and market new products.
Collaborates with Business Unit Regulatory to provide guidance on regulatory requirements and strategies.
Establishes strong partnership with local sales and marketing leadership in aligning regulatory strategies with business objectives.
Maintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision-making, and communicates such knowledge to all who have need to know.
Consults with and provides advice to senior management of the Company on strategies and plans for regulatory product approvals.
Directs staff in implementing regulatory strategy and preparing regulatory submissions.
Other Duties: List any other important but non-essential and/or infrequent duties performed.
Remains current on developments in field(s) of expertise, regulatory requirements, as well as industry trends and trains staff regarding changing regulations that affect regulatory submissions. Maintains knowledge of current and pending regulations through literature, trade journals, professional associations, and by attending conferences.
Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
Performs related functions and responsibilities, on occasion, as assigned.
• Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com