Regulatory Affairs Associate

2 days ago

Lake Forest, United States Talentrupt RPO Full time
Job DescriptionJob Description

Regulatory Affairs Associate

Location: Lake Forest: Conway Park IL 60045

Rate: $33/hr on w2

Duration: 1 year contract on w2

Responsibilities:

  • Provide regulatory input to product lifecycle planning.
  • Evaluate proposed software, hardware and manufacturing changes for regulatory filing strategies.
  • Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
  • Participate in risk benefit analysis for regulatory compliance.
  • Determine and communicate submission and approval requirements.
  • Assist in preparation and review of regulatory submission to authorities.
  • Assist compliance with product postmarketing approval requirements.
  • Submit and review change controls to determine the level of change and consequent submission requirements.
  • Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and on-time delivery of project milestones. Establishes priorities of work assignments.
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.
  • Participates in determining goals and objectives for projects.
  • May organize and lead team meetings.
  • 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.

 

Skill Requirement:

  • 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); Domestic and international regulatory guidelines, policies and regulations; Ethical guidelines of the regulatory profession, clinical research and regulatory process. Note: This knowledge may be developed through tenure in this position.
  • Communicate effectively verbally and in writing. Communicate with diverse audiences and personnel. Write and edit technical documents. Work with cross-functional teams. Work with people from various disciplines and cultures.
  • Write and edit technical documents. Negotiate internally.
  • Pay strong attention to detail.
  • Manage projects. Create project plans and timelines. Think analytically and critically.
  • Organize and track complex information.
  • Exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Has a sound knowledge of a variety of alternatives and their impact on the business.
  • Apply business and regulatory ethical standards.

 

Qualification:

  • 2-3 years experience in a regulated industry (e.g., medical products,medical device software) or 2 years’ experience in software verification/validation, software quality assurance or experience as Medical Technologist with familiarity of software-driven clinical analyzers.
  • Regulatory area with software knowledge is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society or Medical Technologist; ASCP.)

 

Education: Bachelors Degree - In science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.

 

  • Regulatory Affairs Associate

    18 hours ago

    Lake Forest, United States Intellectt Inc Full time

    ​Role: Regulatory Affairs AssociateLocation: Lake Forest, IL (Conway Park)Duration: 12 MonthsJob DescriptionThe Regulatory Affairs Associate is responsible for managing applications and interactions with government agencies to obtain approvals for medical products.​Key responsibilities include:Preparing and submitting PMA supplements such as 30-Day...

  • Regulatory Affairs Specialist

    1 week ago

    Lake Forest, Illinois, United States Collabera Full time

    We are seeking a Regulatory Affairs Specialist to join our team in the Infectious Disease business unit.The successful candidate will be responsible for preparing documentation for EU Technical Files and international product registrations.This is an excellent opportunity for a skilled Regulatory Affairs professional to take their career to the next level...

  • Regulatory Affairs Associate

    1 month ago

    Lake Forest, United States PSG Global Solutions Careers Full time

    Apply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity 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...

  • Regulatory Affairs Specialist

    1 week ago

    Lake Forest, Illinois, United States Collabera Full time

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Collabera. As a key member of our Infectious Disease business unit, you will be responsible for preparing documentation for EU Technical Files and international product registrations.

  • Regulatory Affairs Specialist II

    1 week ago

    Lake Forest, Illinois, United States Collabera Full time

    We are seeking a highly skilled Regulatory Affairs Specialist II to join our team at Collabera. As a key member of our Infectious Disease business unit, you will play a crucial role in preparing documentation for EU Technical Files and international product registrations.This is an exciting opportunity for a talented professional to develop their skills in...

  • Software Regulatory Associate

    2 days ago

    Lake Forest, United States Select Source International Full time

    Job DescriptionJob DescriptionJob Title: Regulatory Affairs AssociateLocation:  Lake Forest, Illinois 60045 - OnsiteDuration:  12 Months Contract with possible extensionShift/Schedule: 1st shift – 8:00 AM – 5:00 PMPay Rate/Range: $35.00/hr on w2 w/o benefitsJob Description:Provide regulatory input to product lifecycle planning.Evaluate proposed...

  • Regulatory Affairs Coordinator

    4 weeks ago

    Salt Lake City, United States ARUP Laboratories Full time

    Description Schedule :Monday - Friday (40 hrs/wk)8:00 AM - 5:00 PM Department: Corp Compliance Office - 241 Primary Purpose : The Regulatory Affairs Coordinator is a member of the Corporate Compliance office and supports the Public Health Reporting team and Compliance Manager. The Regulatory Affairs Coordinator ensures compliance to new and existing...

  • Regulatory Affairs Specialist

    1 week ago

    Salt Lake, Utah, United States Professional Recruiters Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Professional Recruiters. As a key member of our compliance department, you will be responsible for designing, implementing, and maintaining internal controls and policies to ensure adherence to local, state, and federal laws and regulations.The ideal candidate will...

  • Regulatory Affairs Associate

    1 month ago

    Lake Forest, United States Hire Talent Full time

    Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study...

  • Head Of Regulatory Affairs

    6 days ago

    Salt Lake City, United States Tether Operations Limited Full time

    Since its inception in 2014 by pioneering Bitcoin enthusiasts, Tether has not only launched thefirst ‘stablecoin‘, USD₮, but also expanded its horizons into Tether Data, Tether Power, TetherEdu, and more. Our platforms and tokens lead in liquidity, stability, and innovation, setting thefoundation for the future.Tether is committed to the extraordinary,...

  • EU Regulatory Compliance Manager

    2 weeks ago

    Lake Forest, Illinois, United States Collabera Full time

    We are seeking a highly skilled EU Regulatory Compliance Manager to join our team at Collabera. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with EU regulatory requirements for our Infectious Disease business unit.This is an exciting opportunity for a talented professional to develop their skills in...

  • Quality & Regulatory Affairs Specialist I

    1 month ago

    Salt Lake City, United States ARUP Laboratories Full time

    Description Schedule :Monday - Friday (40 hrs/wk)8:00 AM - 5:00 PM Department: Quality Systems & Support - 252 Primary Purpose : The Quality and Regulatory Affairs Specialist I monitors and coordinates organization-wide compliance to current requirements of all quality related regulatory, certifying, licensing, and accrediting agencies. The Quality and...

  • Student Affairs Operations Generalist

    1 month ago

    Forest Grove, United States Pacific University Full time

    Pacific University achieves excellence and distinction by investing in exceptional people to think, care, create, and pursue justice in our world. We embrace discovery in a close nurturing environment that leads to genuine transformation. Our community is diverse, sustainable, and dedicated to discovery and excellence in teaching, scholarship and...

  • Regulatory Litigation Specialist

    7 days ago

    Salt Lake, Utah, United States Denovo Review Full time

    About the RoleDenovo Review seeks an accomplished Senior Litigation and Regulatory Compliance Counsel to lead our company's litigation and regulatory affairs. This individual will oversee complex litigation cases and ensure that our clients are compliant with all applicable laws and regulations.Responsibilities include managing high-profile litigation cases,...

  • Technical Writing Expert

    2 weeks ago

    Lake Forest, Illinois, United States Collabera Full time

    Collabera is seeking a highly motivated and experienced Technical Writing Expert to join our team. As a key member of our Regulatory Affairs department, you will be responsible for developing regulatory documents, including EU Technical Files and international product registrations.This is an excellent opportunity for a talented writer to leverage their...

  • Technical Documentalist II

    1 week ago

    Lake Forest, Illinois, United States Collabera Full time

    About the RoleThis Regulatory Affairs Specialist position involves technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). You will provide regulatory support for diagnostic product development and commercial diagnostic products, developing regulatory strategies for products in development and for modified products...

  • Regulatory Compliance Specialist

    5 days ago

    Lake Forest, Illinois, United States Abbott Full time

    About the RoleWe are looking for a skilled Clinical Research Associate to join our team in Lake Forest, IL.The successful candidate will be responsible for managing sites through the life of trial and close-out, ensuring compliance with applicable Corporate and Divisional Policies and Procedures.Key Responsibilities:Conduct site qualification and initiation...

  • Biopharma Regulatory Affairs Professional

    6 days ago

    Salt Lake, Utah, United States Lifelancer Full time

    Job DescriptionLifelancer is a leading talent-hiring platform in Life Sciences, Pharma, and IT. We are seeking an experienced Analytical Validation Expert to support our Biopharma business unit in developing and executing comprehensive assay analytical validation plans.The successful candidate will possess a Ph.D. or related degree in life sciences, with a...

  • Compliance Expert

    1 week ago

    Lake Forest, Illinois, United States Collabera Full time

    Key ResponsibilitiesThe successful candidate will be responsible for:Preparing documentation for EU Technical Files and international product registrationsProviding regulatory support for diagnostic product development and commercial diagnostic productsDeveloping regulatory strategies for products in development and for modified productsResearching and...

  • Compliance Officer II

    7 days ago

    Lake Forest, Illinois, United States Collabera Full time

    We are seeking a highly motivated Compliance Officer II to join our team in the Infectious Disease business unit.The successful candidate will be responsible for ensuring compliance with regulatory requirements and developing regulatory strategies for products.Key Responsibilities:Analysis of regulatory requirements and development of compliance...