Spec Ii, QA

**Spec II, QA & RA, Bogota**:

- Remote Eligible: Hybrid- Onsite Location(s): Bogota, CUN, CO**Additional Locations**: N/A

**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - 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 Andean Region business objectives as well as provide guidance to employees to facilitate continuous quality and regulatory improvement.
There are three 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.
2) Ensures compliance with Quality System activities (programs, policies, processes, procedures; CAPA, technovigilance, quality audits) to achieve stated objectives.
3) Support Global distributors operation in Andean Region. Manage productive relationships with Distributors, provide clear direction on regulatory needs, strategy to drive timely regulatory submissions.

**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**

**Problem Solving**
Develops solutions to a variety of problems of moderate scope and complexity where analysis of situations or data requires a review of identifiable factors. Exercises judgment to determine appropriate action. Has knowledge of alternatives and an understanding of their impact on the business or technological environment.

**Planning and Organization**
Plans, organizes, and prioritizes own daily work routine to meet established schedule.

**Discretion/Latitude; Supervision Received; Decision Making**
Works under general direction regarding the progress of projects and special assignments. May seek guidance in resolving problems,