Regulatory Affairs Specialist

1 week ago

Lake Forest, United States GForce Life Sciences Full time

Regulatory Affairs Specialist Onsite in Lake Forest, IL

Must be able to work W2

Summary

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 preparing and submitting necessary documentation for registration worldwide.

Day-to-Day Duties

  • Provide regulatory input to product lifecycle planning. Assist in SOP development and review.
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
  • Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
  • Determine trade issues to anticipate regulatory obstacles. Participate in risk benefit analysis for regulatory compliance.
  • Determine and communicate submission and approval requirements. Monitor applications under regulatory review.
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
  • Assist in preparation and review of regulatory submission to authorities.
  • Maintain annual licenses, registrations, listings and patent information.
  • Assist compliance with product postmarketing approval requirements. Assist in the review of advertising and promotional items.
  • Assess external communications relative to regulations. Review regulatory aspects of contracts.
  • Assist with label development and review for compliance before release.
  • Submit and review change controls to determine the level of change and consequent submission requirements.
  • Contribute to the development and functioning of the crisis/ issue management program. Ensure product safety issues and product associated events are reported to regulatory agencies.
  • Provide regulatory input for product recalls and recall communications.
  • Individual may provide limited work direction and guidance to peers and/or skilled non-exempt levels of employees. Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel. Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule. Establishes priorities of work assignments. May lead a departmental project team.
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.
  • Influences middle management on technical or business solutions.
  • May interact with vendors.
  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious delays and considerable expenditure of resources.

Mandatory Requirements

  • Bachelors degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology) math, engineering, or medical fields is preferred
  • 2-3 years of experience in a regulated industry (e.g. medical products, nutritionals)
  • Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents.

Nice to have

  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society)
  • Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents; Regulatory agency structure, processes and key personnel; Principles and requirements of applicable product laws; Submission/registration types and requirements; GxPs (GCPs, GLPs, GMPs); Principles and requirements of promotion, advertising and labeling; Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process.

Term & Start

12-month contract with possibility to extend

FT, M-F 40h/week

Pay Rate: $25-30/hr ($50-60K annually)

Onsite in: Lake Forest, IL

  • Regulatory Affairs Specialist

    3 days ago

    Lake Forest, United States Talentrupt RPO Full time

    Job DescriptionJob Description Job Title - Regulatory Affairs Specialist Location – Lake Forest, IL 60045(Onsite Role)Duration – 12+ months of contract rolePay rate $33/hr on w2 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...

  • Regulatory Affairs Specialist

    6 days ago

    Lake Forest, United States Talentrupt RPO Full time

    Job DescriptionJob DescriptionJob Title - Regulatory Specialist IILocation - Lake Forest, IL12+ months of contract with possibility of extensionPay rate $46 to $55/hr on w2Exempt/Non Exempt: Non Exempt Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or...

  • Regulatory Affairs Specialist

    Found in: Appcast US C2 - 1 week ago

    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...

  • Regulatory Affairs Specialist

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    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...

  • Regulatory Affairs Associate

    Found in: Appcast US C2 - 1 week ago

    Lake Forest, United States GForce Life Sciences Full time

    Regulatory Affairs Associate – Abbott Park, IL Must be able to work on a W2Job Summary: As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at...

  • Regulatory Affairs Associate

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Lake Forest, United States GForce Life Sciences Full time

    Regulatory Affairs Associate – Abbott Park, IL Must be able to work on a W2Job Summary: As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at...

  • International Regulatory Affairs Specialist

    Found in: beBee S US - 2 weeks ago

    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...

  • Regulatory Affairs Associate

    Found in: Appcast US C2 - 1 week ago

    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...

  • Regulatory Affairs Associate

    2 weeks ago

    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...

  • Regulatory Affairs Associate

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    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...

  • Regulatory Specialist II

    6 days ago

    Lake Forest, United States Spectraforce Technologies Full time

    Job Title: Regulatory Specialist II Duration: 12 Months (Possibility of extension) Location: Lake forest, IL (60045) - Open for remote Shift: 8 am - 5 pm Summary: 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...

  • Regulatory Specialist II

    2 days ago

    Lake Forest, United States Spectraforce Technologies Full time

    Job Title: Regulatory Specialist II Duration: 12 Months (Possibility of extension) Location: Lake forest, IL (60045) - Open for remote Shift: 8 am - 5 pm Summary: 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...

  • Regulatory Affairs Specialist

    Found in: Appcast US C2 - 1 week ago

    Round Lake, United States SPECTRAFORCE Full time

    Title: Regulatory Affairs Ops SpecialistDuration: 12 MonthsLocation: Round Lake, IL, 60073Hybrid - 3 days onsite, 2 remoteDescription:• Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types• Creating timelines for regulatory filings• Providing and maintaining templates for...

  • Regulatory Affairs Specialist

    Found in: Appcast Linkedin GBL C2 - 1 week ago

    Round Lake, United States SPECTRAFORCE Full time

    Title: Regulatory Affairs Ops SpecialistDuration: 12 MonthsLocation: Round Lake, IL, 60073Hybrid - 3 days onsite, 2 remoteDescription:• Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types• Creating timelines for regulatory filings• Providing and maintaining templates for...

  • Regulatory Affairs Specialist

    1 week ago

    Round Lake, United States SPECTRAFORCE Full time

    Title: Regulatory Affairs Ops SpecialistDuration: 12 MonthsLocation: Round Lake, IL, 60073Hybrid - 3 days onsite, 2 remoteDescription:• Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other electronic submission types• Creating timelines for regulatory filings• Providing and maintaining templates for...

  • Regulatory Affairs Specialist

    1 week ago

    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...

  • Regulatory Affairs Specialist

    Found in: Appcast US C2 - 1 week ago

    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...

  • Regulatory Affairs Specialist

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    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...

  • Remote Regulatory Affairs Associate

    3 days ago

    Lake Forest, United States Select Source International Full time

    Job DescriptionJob Description Client: Medical DeviceJob Title: Regulatory Affairs AssociateLocation: RemoteDuration: 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...

  • Regulatory Specialist II

    Found in: Appcast US C2 - 5 days ago

    Lake Forest, United States SPECTRAFORCE Full time

    Job Title: Regulatory Specialist IIDuration: 12 Months (Possibility of extension)Location: Lake forest, IL (60045) – Open for remote Shift: 8 am – 5 pmPay Rate Starts from $52/hr on W2 (Negotiable for the right candidate) Summary: The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit. In this role you will...