Remote Regulatory Affairs Associate

2 weeks ago


Lake Forest, United States Select Source International Full time
Job DescriptionJob Description

 Client: Medical Device

Job Title: Regulatory Affairs Associate
Location: Remote
Duration: 12+ Month 

 

  • Duties: candidate will be responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR)… Provides regulatory support for diagnostic product development and commercial diagnostic products. Maintains approvals/licenses/authorizations for existing marketing authorizations.
  • Experience: 4+ years’ experience in Regulatory Affairs role; Strong knowledge of IVDR and EU regulatory requirements is required.
  • Preferred Experience: 1+ years’ experience in an IVD or medical device manufacturing environment
  • Key Skills: Good knowledge of EU and international regulations. Good written & verbal communication skills; Strong time management skills, with the ability to work on multiple projects simultaneously; Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio
  • Education: B.S in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience
  • Location: Manager prefers position to be onsite but will consider remote candidates” 
Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.Company DescriptionSelect Source International (SSI) is an IT, Health Care, and Engineering Services consulting firm that has been in business since 1998. SSI consultants have provided exceptional services that have been appreciated by clients, customers, and users alike at several large Fortune 500 companies, mid-size enterprises, and consulting companies.

  • Lake Forest, United States GForce Life Sciences Full time

    Regulatory Affairs Associate JR Lake Forest, IL MUST BE ABLE TO WORK ON A W2 Job Title: Regulatory Affairs Associate JR Job Summary: The Regulatory Affairs Associate Jr. supports the execution of External Regulations Standards and Guidance Documents packages by tracking and monitoring ePAS packages from draft to final closure. This role prepares metrics...


  • Lake Forest, United States GForce Life Sciences Full time

    Regulatory Affairs Associate JR – Lake Forest, IL MUST BE ABLE TO WORK ON A W2Job Title: Regulatory Affairs Associate JRJob Summary: The Regulatory Affairs Associate Jr. supports the execution of External Regulations Standards and Guidance Documents packages by tracking and monitoring ePAS packages from draft to final closure. This role prepares metrics...


  • Lake Forest, United States GForce Life Sciences Full time

    Regulatory Affairs Associate JR – Lake Forest, IL MUST BE ABLE TO WORK ON A W2Job Title: Regulatory Affairs Associate JRJob Summary: The Regulatory Affairs Associate Jr. supports the execution of External Regulations Standards and Guidance Documents packages by tracking and monitoring ePAS packages from draft to final closure. This role prepares metrics...


  • Lake Forest, United States GForce Life Sciences Full time

    Regulatory Affairs Associate JR – Lake Forest, IL MUST BE ABLE TO WORK ON A W2Job Title: Regulatory Affairs Associate JRJob Summary: The Regulatory Affairs Associate Jr. supports the execution of External Regulations Standards and Guidance Documents packages by tracking and monitoring ePAS packages from draft to final closure. This role prepares metrics...


  • Lake Forest, United States PSG Global Solutions Full time

    Description We're looking for a Regulatory Affairs Associate, working in Biotechnology/Medical Devices industry in 100 Abbott Park Road, Lake Forest, Illinois, 60064, United States. Job description: Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring...


  • Lake Forest, United States DivIHN Integration, Inc Full time

    *Title: Regulatory Affairs Specialist II *Location: Lake Forest, ILDuration: 12 Months*A detailed description of the position will be shared once we get your application**Regulatory Affairs Specialist II **Description*The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit. In this role you will prepare documentation...


  • Lake Forest, United States GForce Life Sciences Full time

    Regulatory Affairs Specialist – Onsite in Lake Forest, ILMust be able to work W2Summary Our client, a Fortune-500 Medical Device Company, has requested that we find them a regulatory affairs specialist to provide support and ensure efficient and compliant business processes and environment. This candidate will assist in the registration of products by...


  • Lake Forest, United States DivIHN Integration Full time

    DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to...


  • Lake Forest, United States Intellectt Inc Full time

    Role: Regulatory Specialist IILocation: Lake Forest, IL, Santa Clara, CA, Boston, MADuration: 6-12 Months RESPONSIBILITIES:Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).Provides regulatory support for diagnostic product development and commercial diagnostic products.Develops regulatory...


  • Lake Forest, United States Intellectt Inc Full time

    Role: Regulatory Specialist IILocation: Lake Forest, IL, Santa Clara, CA, Boston, MADuration: 6-12 Months RESPONSIBILITIES:Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).Provides regulatory support for diagnostic product development and commercial diagnostic products.Develops regulatory...


  • Lake Forest, United States Intellectt Inc Full time

    Role: Regulatory Specialist IILocation: Lake Forest, IL, Santa Clara, CA, Boston, MADuration: 6-12 Months RESPONSIBILITIES:Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).Provides regulatory support for diagnostic product development and commercial diagnostic products.Develops regulatory...


  • Lake Forest, United States INTELLECTT INC Full time

    Role: Regulatory Specialist II Location: Lake Forest, IL, Santa Clara, CA, Boston, MA Duration: 6-12 Months RESPONSIBILITIES: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops...


  • Lake Forest, United States DivIHN Integration Full time

    DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to...


  • Lake Forest, United States VIVA Full time

    Title: Regulatory Specialist - Onsite Description: Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function Skills: Knowledge of regulations and standards affecting IVDs and/or biologics Education: BS preferred in a technical...


  • Round Lake, United States Kelly Science, Engineering, Technology & Telecom Full time

    Kelly Science & Clinical is seeking a Regulatory Affairs Ops Specialist near Round Lake, IL. Long term contract = ~1 year contract Shift: Monday - Friday 1st Hybrid - 3 days onsite, 2 remote Compensation: based on experience Responsibilities: Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic...


  • Round Lake, United States Kelly Science, Engineering, Technology & Telecom Full time

    Kelly Science & Clinical is seeking a Regulatory Affairs Ops Specialist near Round Lake, IL.Long term contract = ~1 year contract Shift: Monday - Friday 1stHybrid - 3 days onsite, 2 remoteCompensation: based on experience Responsibilities:Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission...


  • Round Lake, United States Kelly Science, Engineering, Technology & Telecom Full time

    Kelly Science & Clinical is seeking a Regulatory Affairs Ops Specialist near Round Lake, IL.Long term contract = ~1 year contract Shift: Monday - Friday 1stHybrid - 3 days onsite, 2 remoteCompensation: based on experience Responsibilities:Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission...


  • Round Lake, United States Kelly Science, Engineering, Technology & Telecom Full time

    Kelly Science & Clinical is seeking a Regulatory Affairs Ops Specialist near Round Lake, IL.Long term contract = ~1 year contract Shift: Monday - Friday 1stHybrid - 3 days onsite, 2 remoteCompensation: based on experience Responsibilities:Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission...


  • Salt Lake City, United States bioMerieux SA Career Site - MULTI-LINGUAL Full time

    Description What will be your activities at bioMrieux?The Regulatory Affairs Market team is looking for a Regulatory Affairs Specialist to support Latin America & Canada region in a dynamic regulatory context.The Regulatory Affairs Market team composed of 9 people is in daily contact with the local regulatory teams (subsidiaries and distributors) in order...


  • Lake Forest, United States Collabera Full time

    Job DescriptionJob Description·         The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit.  ·         In this role you will prepare documentation for EU Technical Files and international product registrations.  ·         This job description will be reviewed periodically and is...