The purpose of this role is to provide Quality and Regulatory expertise to support to the local / region / international business objectives as well as promote continuous quality improvement and engagement in quality initiatives.
There are two primary roles : 1) critical in linking with the executive management team for the country / region and in the relationships with the competent authorities / health authorities;
and / or 2) manages and provides oversight to ensure compliance with Quality System activities (programs, policies, processes, procedures).
Regulatory Affairs Responsibilities : Secures regulatory approvals according to specific country requirements and applicable laws;
Monitors local as well as regional regulatory environment and providing updates to business partners; Provides regulatory related information to business country heads, sales managers and customer services and acts as lead national business representative in communications with government regulatory bodies;
Prepares and executes clinical trial notifications to competent authorities; Communicates with competent authorities on field corrective actions, vigilance, etc.
Quality Assurance Responsibilities : Maintains, advises and reports on compliance to Corporate Quality System, International and Local Requirements and Regulations as well as Quality Policies and Procedures to site Management Team and other employees on how to achieve compliance for the aforementioned Quality System elements, as applicable to the site;
Promotes and develops quality awareness in every employee, while helping the site organization towards improved quality performance and ownership as well as customer and regulatory / compliance oriented initiatives;
Monitors, identifies and reports on key Quality System indicators and takes appropriate action to address areas for improvement - May verify implementation of suggested solutions;
Is responsible for continuous Quality System efficiency and effectiveness and promoting solution-driven behavior; Frequently interacts with and represents the quality function to certain BSC departments like Operations, Regulatory, Sales and others, as key Quality System processes are managed by those areas (e.
g. Complaint reporting, Field Action execution, etc) - May also interact with national regulatory authorities; 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;
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.
May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects / programs and / or operations.
Monitor and ensure compliance with company policies and procedures (e.g. federal / country and regulatory requirements).
Job Scope and Leveling Guidelines
Scope : Accomplishes results through professional specialist employees or subordinate managers and supervisors who exercise significant latitude and independence in their assignments.
Provides direction and monitors costs .
What we are looking for in you :
Professional in Industrial Engineering, Pharmaceutical Chemistry, Chemical Engineering or related degrees.
Minimum 6 year of experience in knowledge of ISO 13485 or 9001, Quality System Management and Regulatory Affairs, preferably in medical or related industry.
Languages : English B2, preferably Portuguese.
Requisition ID : 502279
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!