Hologic Regulatory Affairs Specialist CR 1 (GSS) in Alajuela, Costa Rica

Regulatory Affairs Specialist CR 1 (GSS)

Post Date Dec 03, 2018

Summary of Duties and Responsibilities:

Support and provide input to project teams to asssure regulatory authority requirements are

incorporated as part of the product development process and during sustaining activities.

Support and participates in multi-departmental teams to implement the regulatory strategies

for submissions by determining and obtaining the necessary information required to support

submissions.

Supports international registration activities.

Support the interpretation of existing or new international regulatory guidelines as they relate

to company products, procedures, and policies.

Serve as the site Super-Admin user for BSI BSOL/Compliance Navigator standards.

Support interaction with outside agencies such as international legal authorities, legal counsel,

and other consultants.

Support the preparation/revision of regulatory procedures as required.

May include other duties as defined by the Director, QA and Regulatory Affairs or Regulatory

Affairs Manager (Corporate).

Qualifications: To perform this job successfully, an individual must be able to perform each

essential duty satisfactorily. The requirements listed below are representative of the basic

knowledge, skills, and/or abilities required:

Skills/Competencies:

Excellent written and verbal communication skills in English and Spanish.

Proficient in attention ot detail.

Excellent organizational skills.

Good negotiation and interpersonal skills.

Ability to independently plan, execute, and/or problem solve moderate to complex situations.

Ability to exercise judgment within generally defined practices and policies in selecting methods

and techniques for obtaining solutions.

Must demonstrate initiative, balanced assertiveness working as a team player.

Computer literate: strong working knowledge of word processing; familiarity with spreadsheet

programs and other related programs. (Agile/Visio/Project/Oracle)

Excellent ability to read, analyze and interpret technical documents, professional journals,

technical procedures and government regulations.

Good presentation skills.

Good interpersonal skills to interact with all levels of the company, sometimes in an adversary

role.

Education: Bachellor Degree career plan in a life sciences, engineering or related discipline.

Experience:

Experience working in a medical device GMP/ISO medical device manufacturing environment

General understanding of worldwide medical device regulations and regulated environment

Specialized Knowledge: Regulatory Affairs certified professional would be desirable.

Languages required for the position: English and Spanish.

Computer tools and knowledge level required:

Microsoft Office: Intermediate Level

Others Tools: Oracle