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Regulatory Affairs Specialist CR 1 (GSS)

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Regulatory & Quality Assurance
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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

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