Superior Jobs


Regulatory Affairs Specialist

  • ID: 475281
  • Posted: 12/7/2020
  • Location: Chaska, MN
  • Category: Pro - Professional
  • Job Type: Temporary
  • Duration: 3 - 6 Months


Acara Solutions is looking for Regulatory Affairs Specialist for our Client located in Chaska, MN.
  • The primary purpose of this job is to execute and provide input on regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets, and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards.
  • Adheres to GB Core Beliefs and all safety and quality requirements.
  • Develops international regulatory strategies for product submissions, identifying and tracking international requirements.
  • Works with minimal consultation/guidance from senior department members, participates on Product Development teams, providing input in regulatory, strategy, timelines, and direction.
  • Initiates FDA export approval requires and product release authorizations.
  • Assists with recall/retrieval documentation and other activities.
  • Develops and maintains regulatory status documents and submission procedures and international regulatory requirements database.
  • Assists senior staff with implementation of new methodologies associated with product quality and quality systems.
  • Performs other functions.
  • What day are you looking to have someone start, what is the estimated length of assignment. 
  • That would depend on the level of knowledge in the person we are looking for if we have to train on European regulations than as soon as mid-Dec.
  • If the person has regulation knowledge and it would just be a matter of getting them up to speed on our specific submissions then it could wait until after the first of the year. 
  • This need is predicated on parental leave is due very early March. 
Job Requirements

Required Skills / Qualifications:
  • Bachelor"s degree 
  • Minimum of 5 years" experience in organizing and accurately controlling large amounts of detailed information.
  • Minimum 2 years of US and International medical device industry experience preparing documents for regulatory submission/approval.
Preferred Skills / Qualifications:
  • Experience with class III/Implantable devices. 
  • Knowledge of FDA Quality System regulations and ISO requirements and documents.
  • Ability to work in a team environment. 
  • Highly organized and able to work on and track multiple project simultaneously.
  • Excellent written and oral communications, Ability to communicate effectively with individuals speaking multiple languages.
  • Ability to research current international requirements. 
  • Ability to address concurrent demands from multiple sources. 
  • Skill in working with computers and experience with spreadsheet and word-processing software.
  • Knowledge of and submission experience with the EU Medical Device Regulation (MDR) preferable.
Additional Information:
  • Upon offer of employment, the individual will be subject to a background check and a drug screen.

Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct, and Aleron?s strategic partner, SDI) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender identity, sexual orientation, national origin, genetic information, sex, age, disability, veteran status, or any other legally protected basis. The Aleron companies welcome and encourage applications from diverse candidates, including people with disabilities. Accommodations are available upon request for applicants taking part in all aspects of the selection process.

Applicants for this position must be legally authorized to work in the United States. This position does not meet the employment requirements for individuals with F-1 OPT STEM work authorization status.

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