Global Regulatory Affairs Specialist - FDA, FSMA & ISO 13485
Sterigenics
Sterigenics U.S. LLC is seeking a Regulatory Affairs Specialist in the United States to support regulatory strategy, registrations, and listings for multiple sterilization sites. You will collaborate with Quality, Ops, and Sales to guide customers from onboarding through commercialization. The role requires a life sciences or related degree and 2+ years in regulatory affairs with knowledge of FDA, ISO 13485, FURLS, and CDERDirect. Training and cross-functional collaboration are emphasized. #J-18808-Ljbffr Sterigenics
$63k - $95k
## Regulatory Affairs SpecialistApplylocations: Oak Brooktime... ..., Safeguarding Global Health.Sotera... ...Affairs Specialist supports the regulatory... ...Modernization Act (FSMA) as a Preventive... ...FDQI).* Manage the FDA annual update... ...knowledge of FDA, ISO 13485, and other applicable...SuggestedImmediate startWorldwideFlexible hours- ...The Regulatory Affairs Level III (Senior Specialist) position is responsible for global product registrations and ensuring regulatory compliance... .../or De Novo submissions for FDA Technical documentation for... ...In-depth knowledge of ISO 13485, FDA regulations (including...Suggested
$50k - $60k
...oriented Import Compliance Specialist to support our... ...Border Protection (CBP), FDA, USDA, and other applicable regulatory requirements. This position... ...international logistics, or global trade. Working knowledge... ...Knowledge of FDA Prior Notice, FSMA, food labeling...SuggestedPermanent employmentFull timeH1bOverseas$63k - $95k
Sterigenics U.S., LLC is searching for a Regulatory Affairs Specialist in Oak Brook, Illinois. This role involves supporting regulatory strategies and ensuring compliance with global regulatory bodies. The successful candidate will assist the Regulatory Affairs Manager...Suggested$75k - $113.5k
...Salesforce.com, inc. in Chicago is seeking a Global Trade Compliance professional with over 5 years of experience. The role involves managing ITAR compliance, maintaining HTS codes, and ensuring the integrity of global trade practices. The ideal candidate will be skilled...Suggested- N.A. Trading Company seeks an Import Compliance Specialist to safeguard our international sourcing and import operations. You will ensure shipments meet CBP, FDA, USDA and other regulatory requirements, coordinating with brokers, suppliers, and internal teams. The ideal...
- ...Safety Consultant to perform independent audits of digital platforms and services. This position involves ensuring compliance with global privacy and safety regulations such as GDPR and CCPA. The successful candidate will use their expertise in privacy testing, conduct...
- Sotera Health Company in Oak Brook is seeking a Regulatory Affairs Specialist to support regulatory strategy, prepare listings, and ensure compliance... ...in regulatory affairs. This role includes managing FDA annual updates, training Customer Service staff, and acting...
- ...frontier AI models used by top research teams globally. Organization : Alignerr Type... ...scenarios across frameworks like SOC 2, ISO 27001, and NIST Assess risk statements... ...security consulting Familiarity with regulatory compliance areas such as HIPAA, PCI-DSS,...Hourly payOngoing contractContract workFreelanceRemote workWorldwideFlexible hours
- ...relevant experience and a strong commitment to ethical practices. This role offers the opportunity to positively impact Kearney’s global compliance and integrity culture, requiring collaboration across teams and the ability to manage multiple projects effectively. A competitive...
- Addison Group is partnering with a global management consulting organization to identify a Risk & Compliance Associate. This role supports the organization's global compliance, ethics, and enterprise risk management initiatives, collaborating with cross‑functional teams...
$80k
...are seeking a Trade Compliance Specialist with strong experience in... ...collaborates closely with SRAM's global teams to ensure consistency... ...Compliance Manager. Responsibilities Regulatory and Compliance Management:... ..., CBP's ACE Portal, CROSS, FDA, APHIS, and U.S. HTS...Temporary workWork at office- ...A family-owned confectionery company is seeking a Regulatory Affairs Specialist to support compliance and documentation for their products. The ideal... ...ingredient specifications, ensuring compliance with FDA regulations, and collaborating cross-functionally. This full...Full timeRemote work
- ...systems. Responsibilities include coordinating tax legislation reviews, training team members, and identifying process improvements. Join our team in Chicago, Illinois, and help maintain compliance across our global payroll operations. #J-18808-Ljbffr Anywhere Real Estate
$98.1k - $156.2k
...everything starts with our people. We're a global close‑knit community, united by the... ...Description Support Motorola Solutions to obtain regulatory product compliance for mobile video... ...18031-2, ETSI EN 303 645 Automotive EMC: ISO 7637, EN 50498 Experience testing to technical...RelocationFlexible hours- Belltower Fund Group is seeking an experienced operator to support global compliance obligations. This remote role focuses on ensuring a seamless experience for fund managers and limited partners by managing workflows and project initiatives. Qualifications include 2+...Remote job
- ...2+ years of GRC experience, you will classify scenarios against SOC 2, ISO 27001, and NIST CSF, and offer thoughtful, independent analysis. This remote hourly contract offers flexible hours and ongoing collaboration with global research teams. #J-18808-Ljbffr AlignerrRemote jobHourly payContract workFlexible hours
- Zero Hash is seeking a Travel Rule Specialist in Chicago, responsible for monitoring travel rule transactions and ensuring compliance. The ideal candidate will possess at least 2 years of compliance experience and knowledge of travel rule requirements in the US, UK, EU...Remote work
- Livingston International is seeking a Customs Brokerage professional based in Chicago. The role involves ensuring accurate and timely processing of shipments, creating customs entries, and maintaining compliance with regulations. Candidates should have a High School Diploma...
$95k - $125k
...in Chicago Senior IT Compliance Analyst - Global Building Materials Leader A leading... ...for senior leadership Stay current with regulatory changes, audit standards, and best practices... ...control frameworks such as COBIT , NIST , or ISO 27001 Strong understanding of ITGCs,...Full timeRemote work$67.1k - $94.75k
...Alliant Credit Union (ACU) is compliant with regulatory and legal obligations. Help maintain the... ...standards (e.g. FFIEC, GLBA, SOX, SOC 2, ISO, NIST, COSO, COBIT, PCI-DSS, GDPR, etc.)... ..., IL $75,000.00-$125,000.00 2 days ago Global Process Manager, Compliance, Sanctions Operations...Full timeTemporary workPart timeWork from home3 days per week- Katalyst CRO in Chicago seeks a Regulatory Affairs Level III (Senior Specialist) to manage global product registrations and ensure compliance in the medical device sector. The role involves developing regulatory strategies, leading 510(k) submissions, and supporting quality...
- Creative Solutions Services, LLC is seeking a Regulatory Affairs professional to support RIM activities, maintain regulatory records, and ensure compliance. This role is ideal for recent graduates looking for exposure in regulatory operations. The successful candidate...
- ...excellence and a focus on the future. As a Regulatory Affairs Specialist , you will play a key role in... ...ensure our packaging and labels meet FDA and other relevant standards. Key Responsibilities... ...labeling regulations (CFR Title 21, FSMA) Experience with ingredient vetting...Full timeRemote work1 day per week
- JazzHR is looking for a Customs Affairs Specialist based in Chicago to facilitate the import of goods. The role requires a minimum of an Associate degree and 2+ years of experience in Customs entry writing. Responsibilities include submitting Customs documentation and...
$65k - $85k
Regulatory Affairs Specialist, North America Location: Chicago, US, 60654 The Regulatory Affairs Specialist is responsible for ensuring compliance... ...and the U.S. markets. Provide feedback and guidance to global teams regarding local legislation, communicating potential...Work experience placementLocal area- N.A. Trading Company seeks a Customs Compliance Specialist to support international import operations by ensuring CBP compliance and accurate documentation. You will work with customs brokers, freight forwarders, overseas vendors, and internal teams to ensure timely, compliant...Overseas
$50k - $60k
...oriented Import Compliance Specialist to support our... ...Border Protection (CBP), FDA, USDA, and other applicable regulatory requirements. This position... ...international logistics, or global trade. ~ Working knowledge... ...Knowledge of FDA Prior Notice, FSMA, food labeling...Permanent employmentFull timeH1bWorldwideOverseas$85k - $95k
...As a global medtech company, we are driven by our Vision of... ...course of lives. The Regulatory and Clinical Specialist will support the clinical evaluation... ...understanding of EU and FDA regulations and guidance... ...medical device regulatory affairs or a Ph.D. with at least 3...Remote workWorldwideFlexible hours$142.5k - $237.5k
...audience products. You will provide guidance on U.S. marketing law and global privacy laws as they apply to advertising technology, supports product development and enhancements and lead regulatory impact assessments. In this role, you will report to the Senior Director...Full timeTemporary workFixed term contractWork experience placementWork at officeFlexible hours2 days per week
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