RAQA Analyst - Lima

at  Boston Scientific Corporation

REQUIREMENTS:

• Graduated in Pharmacy, Biochemistry.
• 2 years professional experience in a multinational company in Regulatory Affairs and or Quality.
• Languages: English level B2 or above
  We are looking for: communication skills, passionate about team work and collaboration, empowered decision maker, results and relationship building oriented, purpose driven.

KEY RESPONSABILITIES

• Regulatory Affairs Responsibilities: Prioritize, plan and execute on product registration and re-certifications for his/her respective product lines; Lobby the local health authorities using constructive/scientific challenges to regulations - This should include guidance on alternative solutions to country regulatory needs; Supports tender operations by timely supply of accurate regulatory documents; Establish and maintain a good working relationship with regional and divisional RA peers to gain positive & timely support for document preparation, submission and approval; Serves as regulatory consultant to marketing team and government regulatory agencies, 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
  Requisition ID: 576391
  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!
  Job Segment: Compliance, Regulatory Affairs, Law, QA, Quality Assurance, Legal, Quality, Technolog

The purpose of this role is to provide Quality and Regulatory expertise to support business objectives and provide guidance to employees to facilitate continuous quality and regulatory improvement.