Regulatory Affairs Intern

hace 2 semanas

Heredia, Costa Rica Boston Scientific Corporation A tiempo completo

**Regulatory Affairs Intern - Escazu - Costa Rica**:

- Remote Eligible:
- Onsite Location(s): Heredia, 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.

**Purpose statement**

To develop competence in strategic and/or operational work while performing in a professional work situation with emphasis placed upon training and development, and to expand professional preparation experiences far beyond the potential inherent in classroom and laboratory activities. Each internship is unique, based on matching the educational and career objectives of the student to the activities of a particular functional area and its specific needs. The internship will focus on a major project for the entire period. Student Interns are expected to learn from the experience as well as contribute to BSC's goals. Internships are typically designed for undergraduate engineers, and graduate engineers. Interns are expected to learn from the experience as well as contribute to Boston Scientific's goals.

What We’re Looking For**:RA Intern**

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

Hybrid, Location: 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)

**Key Responsibilities**
- Works on specific functional area objectives or projects that may require research, working in teams, developing presentations, designing strategies, and keeping abreast of current industry events, market trends, or competitors’ products.
- Conducts her/himself as a regular full-time member of the staff by accepting and adhering to BSC's rules and regulations and by always engaging in professional and personable conduct with staff and customers. The intern is also obligated to comply with any confidentiality and professional policies established by Boston Scientific.
- Becomes knowledgeable about her or his own responsibilities and the business and operational issues inherent in them as well as about the BSC's management and particular issues relevant to the Company.
- Contributes to the preparation and production of proposals and reports by using word processing, spreadsheets, and other computer programs.
- Prepares an oral and written evaluation for presentation to Management upon completion of internship.

**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**

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 co

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