Regulatory Affairs Associate
3 days ago
Title: Regulatory Affairs Associate
Location: North Chicago, IL 60064 (100% On-Site Role)
Contract: 12 months of contract to start with possible extension
Job 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 will execute tasks to evaluate product and software changes in consideration of regulatory guidance documents and regulations.
• The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.
Main 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 post marketing 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.
Education:
• Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred or an equivalent combination of education and work experience.
Experience/Background:
• Minimum 2 years, this position does not require previous regulatory experience.
• 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.
• 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.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society or Medical Technologist; ASCP.).
-
Regulatory Affairs Associate
3 days ago
North Chicago, United States Intellectt Inc Full timeRole: Regulatory Affairs AssociateLocation: Abbott Park, IL 60064Key Responsibilities:Assist in the preparation, review, and submission of regulatory documents for new and existing medical devices.Support the regulatory team in ensuring compliance with U.S. FDA regulations, EU MDR, and other international regulatory standards.Monitor and track the regulatory...
-
Regulatory Affairs Associate
2 days ago
North Chicago, United States Intellectt Inc Full timeRole: Regulatory Affairs AssociateLocation: Abbott Park, IL 60064Key Responsibilities:Assist in the preparation, review, and submission of regulatory documents for new and existing medical devices.Support the regulatory team in ensuring compliance with U.S. FDA regulations, EU MDR, and other international regulatory standards.Monitor and track the regulatory...
-
Regulatory Affairs Associate
3 days ago
North Chicago, United States Cynet Systems Full timeJob DescriptionJob DescriptionWe are looking for Regulatory Affairs Associate for our client in Abbott Park, ILJob Title: Regulatory Affairs AssociateJob Location: Abbott Park, ILJob Type: ContractJob Description:Pay Range: $28.51hr - $33.51hrResponsibilities:As an individual contributor, the function of a Regulatory Affairs Specialist is to provide...
-
Regulatory Affairs Associate
2 days ago
North Chicago, United States Intellectt Inc Full timeRole: Regulatory Affairs Associate(Medical Devices)Location: Abbott Park, IL - 60064Duration: 12 MonthsThe Regulatory Affairs Specialist ensures regulatory compliance and supports efficient business processes. This role evaluates product and software changes, assists in product registrations, and provides regulatory guidance throughout the product...
-
Regulatory Affairs Associate
2 days ago
North Chicago, United States Intellectt Inc Full timeRole: Regulatory Affairs Associate(Medical Devices)Location: Abbott Park, IL - 60064Duration: 12 MonthsSkills Looking For:Background in software regulatory requirements, particularly related to USFDA evaluation of software changes.Experience in software quality assurance, validation testing, or defect analysis in a regulated industry (preferably medical...
-
Regulatory Affairs Associate I
3 months ago
North Chicago, United States Collabera Full timeJob DescriptionJob Description· What are the top 3-5 skills, experience or education required for this position:· eCTD submission publishing (advertising and promotional 2253 submissions if possible)· US regulatory FDA guidelines/CFR submission/regulatory project management Veeva Promomats...
-
Regulatory Affairs Expert
4 weeks ago
Chicago, Illinois, United States Adtalem Global Education Full timeAbout the RoleWe are seeking a highly skilled Senior Regulatory Affairs Analyst to join our team at Adtalem Global Education.Job SummaryThe Senior Regulatory Affairs Analyst will be responsible for interpreting statutes, regulations, and administrative rules of various issuing bodies and developing procedures and processes to assure compliance with those...
-
Regulatory Affairs Specialist
1 week ago
Chicago, Illinois, United States Jeeter Full timeRegulatory Affairs Specialist PositionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Jeeter. As a key member of our distribution compliance team, you will be responsible for ensuring that all cannabis distribution activities comply with state and federal regulations.In this role, you will oversee the tracking and reporting...
-
Associate Director of Regulatory Affairs
4 weeks ago
Chicago, IL, United States Tempus AI Inc. Full timePassionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical...
-
Regulatory Affairs Specialist
1 week ago
Chicago, Illinois, United States Adtalem Global Education Full timeJob OverviewAdtalem Global Education is a leading provider of post-secondary education and professional talent to the healthcare industry. As a Senior Regulatory Affairs Analyst, you will play a critical role in ensuring compliance with federal, state, and internal standards and regulations. This position requires strong organizational, interpersonal, and...
-
Regulatory Affairs Associate
4 weeks ago
Chicago, IL, United States Katalyst Healthcares & Life Sciences Full timeJob Description Company Description: Katalyst HealthCares & Life Sciences Inc. is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics, and medical devices. We are an E-Verified company, looking for prospective candidates on OPT and CPT and we also provide H1B (CAP and CAP exempt) and Green Card...
-
Regulatory Affairs and QA Professional
2 weeks ago
Chicago, Illinois, United States Envision Unlimited Full timeEnvision Unlimited is seeking a Regulatory Affairs and QA Professional to ensure compliance with Illinois Rule 116 and other state and federal regulations. This role requires a strong understanding of regulatory requirements and experience in quality assurance or compliance in healthcare. If you have a Bachelor's degree in nursing (BSN) or related field and...
-
Senior Regulatory Affairs Professional
2 weeks ago
Chicago, Illinois, United States Adtalem Global Education Full timeEstimated Salary:$120,000 - $180,000 per year, depending on experience and location.The Senior Regulatory Affairs Analyst is responsible for interpreting statutes, regulations, and administrative rules of various issuing bodies and developing procedures and processes to assure compliance with those rules.Works with colleagues to ensure processes and...
-
Regulatory Affairs Trade Compliance Manager
1 month ago
Chicago, United States Glanbia Nutritionals Full timeJob description:SENIOR MANAGER REGULATORY & TRADE COMPLIANCE The Opportunity We are seeking a seasoned Regulatory Affairs Manager to oversee the regulatory aspects of our dairy and non-dairy products in North America. This role is pivotal in ensuring compliance with all applicable export control laws and import regulations in territories where our...
-
Regulatory Affairs Coordinator
7 days ago
Chicago, Illinois, United States International Matex Tank Terminals Full timeRegulatory Affairs Coordinator wanted for International Matex Tank Terminals! As a key member of our EHS team, you will be responsible for ensuring our facilities comply with environmental regulations.Your duties will include:Reviewing and implementing environmental regulations and standardsDeveloping and maintaining environmental policies and...
-
Chicago, United States Invenergy Full timeInvenergy drives innovation in energy. Powered by decades of entrepreneurial experience and unparalleled execution, we solve the energy challenges facing our customers and communities. We provide power generation and storage solutions at scale around the world to create a cleaner energy future. We develop. We build. We own. We operate. We are Invenergy. Job...
-
Regulatory Affairs Expert
2 weeks ago
Chicago, Illinois, United States Barton Staffing Solutions Full timeBecome a key player in ensuring regulatory compliance for a leading chemical manufacturing company in the Chicago area. As a Regulatory Specialist, you will be responsible for monitoring and interpreting federal, state, and local regulations pertaining to chemical production, handling, and distribution.The ideal candidate will have 3+ years of experience in...
-
Global Regulatory Affairs Manager
2 weeks ago
Chicago, Illinois, United States Cannon Equipment Full timeJob DescriptionCannon Equipment is seeking a Global Regulatory Affairs Manager to join our team. As a key member of our compliance team, you will be responsible for ensuring our company's adherence to global regulatory requirements, including anti-bribery and anti-corruption laws, import & export regulations, and cybersecurity & privacy regulations.About...
-
Director of Regulatory Affairs, argenx US
3 weeks ago
Chicago, United States argenx Full timeJoin us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to...
-
Clinical Research Regulatory Coordinator
3 weeks ago
Chicago, United States SimplyApply Full timeLocation: Chicago, ILHospital: Rush University Medical CenterDepartment: Research Affairs-ResAdmWork Type: Full Time (Total FTE between 0. 9 and 1. 0)Shift: Shift 1 Work Schedule: 8 Hr (9:00:00 AM - 5:00:00 PM) Rush offers exceptional rewards and benefits learn more at our Rush benefits page.Summary:This positions provides regulatory support for multiple...