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Analyst Jr. RAQA - Lima, Peru Job

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Lima, LIM, PE

Additional Locations: Peru-Lima

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

Purpose Statement
The purpose of this role is to provide Quality and Regulatory expertise to support to the local/region/international business objectives as well as provide guidance to employees to facilitate continuous quality improvement.  There are two primary roles: 1) critical in ensuring rapid and timely approvals for respective product lines including the management of all product registrations and provides management team with regular updates on product registration and new regulations from government body competent authorities/health authorities; and/or 2) ensures compliance with Quality System activities (programs, policies, processes, procedures) to achieve stated objectives.

Key Responsibilities 

  • Regulatory Affairs Responsibilities: Prioritize, plan and execute  on product registration andre-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.

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.

Job Scope and Leveling Guidelines 

Knowledge 
An entry level professional. General knowledge and application of technical and business concepts, procedures, and practices. Interprets company policies and procedures to resolve issues. Beginning knowledge of industry practices and standards.

Problem Solving 
Applies professional concepts and company policies and procedures, analyzes data or situations, and exercises judgment to recommend solutions to solve  problems.  Follows standard practices and procedures in analyzing situations or data from which answers can be obtained.

Planning and Organization 
Plans, organizes, and prioritizes own daily work routine to meet established schedule with guidance from manager.

Discretion/Latitude; Supervision Received; Decision Making 
Receives general supervision.  Makes recommendations which may be reviewed by manager.  May exercise authority within limits.  May seek guidance in resolving problems.

Business Relationships and Project Management 
Begins establishing and cultivating internal business relationships to facilitate completion of tasks. May participate in project teams.

Impact 
Participates in the completion of departmental projects and goals. Errors in judgment or failure to achieve results would normally require an expenditure of resources to rectify.

Liaison 
Engages with internal company and occasional external contacts. Uses discretion, diplomacy and tact in interactions.

What we are looking for in you: 
Graduated in Pharmacy, Biochemistry, Biomedical Engineering, Science. . Licensed to be Assistant to the Technical Director.
 +2 years professional experience in a medical device multinational company.
Languagues: English level B2 or above.
Superb communication skills, passionate about team work and collaboration, empowered decision maker, results and relationship building oriented, influencer, purpose driven

 

Requisition ID: 530316

 

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!


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