Regulatory Affairs Intern

hace 3 semanas

San José, Costa Rica Boston Scientific Corporation A tiempo completo

**Work mode**:
**Onsite Location(s)**:San José, H, CR**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.What We’re Looking For**:RA Intern**

**Career**: Student in Engineer, Pharmaceutical, Chemical, Biotechnology, Biomedical or health related.

Hybrid, Location: Escazú, Costa Rica.

**What we are looking for**:

- Intern supports RA Specialists with regulatory activities in general from Central America´s countries: Learning at MoHs, processes, regulations, best practices, activities, and projects with LATAM.
- Interest in learning regulatory affairs activities and medical devices local regulations.
- This role focuses on regulatory support, with a wide variety of regulatory tasks working within a collaborative team.
- Ensure an understanding of the regulatory process.
- Organization / focus on detail / likes to read in detail.
- Open study area for people interested in the regulatory area.
- Knowledge in data automation.
- Coordinate regulatory documentation activities and maintain data in information systems or databases.
- Create and execute timely manner the Work Plan for submissions, renewals, and amendments of the regulatory projects and ensure full compliance with regulations of the products in charge.
- Evaluate applicable laws and regulations to determine impact on company activities.
- Strong communication skills.
- Ability to think strategically and innovatively.
- Eager to learn.
- Level of English: advanced (at least B2)

**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 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**

Applies limited knowledge of basic technical concepts and practices and a basic understanding of product or systems fundamentals.

**Cognitive Skills**

Performs routine technical tasks working from detailed written or verbal instructions. Performs routine set-up, testing, repair, inspection, and/or maintenance of certain area-specific equipment, materials, systems, and/or product.

**Supervision Received**

Close supervision. Receives detailed instruction on all assignments and constant checking of work assignments.

**Consequence of Errors**

Errors can be easily and quickly detected within the immediate work unit and would result only in minor disruption or expense to correct.

**Contacts**

Contacts are primarily within immediate work unit. Contacts involve obtaining or providing information requiring little explanation or interpretation.

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

**Requisition ID**:576828- **Job Segment**:Regulatory Affairs, Compliance, Law, Pharmaceutical, Biomedical Engineering, Legal, Science, Engineering

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