Job Description - Regulatory Affairs Specialist in Bloomington
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Regulatory Affairs Specialist

Ref: US_EN_6_971597_1420140

Posted on 28 December 2021
Job Location
Bloomington, Indiana
Contract Type

We are looking for a Regulatory Affairs Specialist for a leading company.

Primary Function

The Regulatory Affairs Specialist II responsibilities are narrowly focused to a specific country and/or region in which the Specialist has proficient language skills (reading/writing/speaking). This position requires the ability to speak, read and write in business level region specific language for purposes of communicating with regulatory authorities and international and local offices or distributors. The Regulatory Affairs Specialist II develops regulatory strategies, obtains and maintains approvals, and serves as a communication liaison between manufacturer and the the companies International Local Office / Distributor.

Essential Job Functions/Duties

  • Communicate and interface directly with regulatory authorities to ensure

product approvals are achieved in a timely manner

  • Communicate Country/region-specific regulatory requirements to the

Regulatory Specialist/Regulatory Science team leaders and assist with the

regulatory strategies

  • Develop regulatory strategies, obtain and maintain product approval, and

serve as a communication liaison on regulatory issues between our

manufacturer and our International Local Office and/or Distributor

  • Plan and prepare regulatory submissions for new products, product changes,and re-registrations as required for the specific countries/regions
  • Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability
  • Perform translation activities
  • Collaborate with Regulatory Scientific Affairs on all high risk devices

and new technologies

  • Collaborate with the Clinical Functional Unit on projects requiring the

collection of clinical data

  • Provide support to currently marketed products as necessary including

input on change requests, etc.

  • Maintain and organize appropriate regulatory records to demonstrate

compliance with applicable regulations

  • Must work and interact effectively and professionally with and for others

throughout various levels of the global organization

  • Must strictly adhere to safety requirements
  • Maintain regular and punctual attendance
  • Must maintain company quality and quantity standards
  • Must have effective oral and written communication skills
  • Excellent problem solving skills and ability to work in collaborative and

independent work situations and environments with minimal supervision

  • Ability to remain calm and receptive in fast paced situations

Minimum Work Experience/Educational Requirements

  • Proficient in reading, writing and speaking region specific language(s)
  • Bachelors degree in a life science (preferably biology or

chemistry), engineering, or other related field (such as law); or

experience of such kind and amount as to provide a comparable


Physical Requirements/Work Environment

  • General office environment
  • Sits for extended periods
  • Requires close visual acuity when working with computers, etc.
  • Requires occasional early morning or late evening teleconferences
  • International and domestic travel as required

Employee Requirements

Sign non competition and confidentiality agreements. Compliance with all policies of the company including without limitation the Employee Manual, Code of Conduct, Electronic Information Policy, Product Complaints, HIPAA regulations and Policy & Guidance On Interaction with Healthcare Professionals

This job description in no way states or implies that these are the only duties to be performed. This position is expected to follow other job-related instructions and duties. 

Equal Opportunity Employer/Veterans/Disabled

The Company will consider qualified applicants with arrest and conviction records.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records

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