Regulatory Affairs Specialist III
Careers Integrated Resources Inc
Regulatory Affairs Specialist IIIWhen you're part of ***, you'll do challenging work while collaborating with a team that values performance, quality, innovation, and continuous improvement. Our global organization enables our customers to make the world healthier, cleaner, and safer by delivering industry-leading technologies and solutions.As a Regulatory Affairs & Product Stewardship Specialist within the Filtration & Separation business, you will support regulatory and product stewardship activities for a diverse portfolio of filtration, purification, bioprocessing, and life sciences products. This position plays a critical role in helping ensure products remain compliant, safe, and sustainable throughout their lifecycle while supporting business growth, innovation, and customer success.Key Responsibilities: Regulatory Strategy & ComplianceDevelop and execute global regulatory strategies that support new product commercialization and lifecycle management.Interpret emerging global regulations and communicate regulatory impacts to business stakeholders.Provide regulatory guidance throughout product development, change management, and product discontinuation activities.Ensure compliance with applicable global chemical, environmental, product safety, and industry-specific regulations.Support regulatory submissions, product registrations, declarations of conformity, and compliance documentation where applicable.Product StewardshipLead product stewardship activities throughout the entire product lifecycle.Conduct product hazard, exposure, and risk assessments.Evaluate product composition for regulatory compliance and sustainability objectives.Partner with R&D and Product Management to identify regulatory risks early during product development.Develop mitigation strategies that balance regulatory compliance, customer expectations, and business objectives.Support responsible chemical management and sustainable product design initiatives.Global Regulatory ComplianceProvide expertise in applicable regulations including, but not limited to:TSCAREACH and UK REACHGHS and CLPRoHSProposition 65PFAS regulationsFood Contact regulationsDrinking Water regulationsBiocide regulationsChemical inventory requirementsHazard Communication standardsFDA and USP requirements, where applicableNew Product Introduction (NPI):Participate as the Regulatory Affairs and Product Stewardship representative on global product development teams.Support Stage Gate and design review processes.Review product claims, labels, instructions for use, technical literature, and marketing materials.Ensure regulatory requirements are incorporated into commercialization activities.Evaluate product changes for regulatory impact and coordinate required actions before implementation.Cross-Functional CollaborationPartner closely with:Research & DevelopmentQualityManufacturingOperationsEnvironmental Health & SafetySupply ChainProcurementMarketingSalesLegalGlobal Regulatory Affairs to ensure regulatory compliance while supporting business objectives and operational excellence.Customer & Commercial Support:Respond to customer regulatory inquiries.Prepare compliance letters, declarations, certificates, and technical documentation.Support customer audits and regulatory assessments.Review customer questionnaires regarding product compliance and chemical content.Partner with Commercial teams to resolve customer regulatory concerns.Regulatory Intelligence:Monitor emerging global regulations affecting Client products and markets.Assess business impact and develop implementation strategies.Communicate regulatory changes to leadership and cross-functional teams.Participate in industry associations and professional organizations to maintain current regulatory knowledge.Quality & Risk Management:Support Quality Management Systems including ISO 9001 and ISO 13485 where applicable.Participate in product risk assessments and Failure Mode and Effects Analysis (FMEA) activities.Contribute to continuous improvement initiatives that strengthen compliance and operational effectiveness.Support internal and external audits.Minimum Qualifications:Bachelor's degree in Chemistry, Chemical Engineering, Biology, Toxicology, Environmental Science, Materials Science, Life Sciences, Engineering, or another related scientific discipline.Minimum five (5) years of experience in Regulatory Affairs, Product Stewardship, Environmental Health & Safety, Product Compliance, Quality, or related technical functions.Demonstrated experience supporting global regulatory compliance programs.Experience working in cross-functional technical teams.Excellent written and verbal communication skills.Strong analytical, organizational, and project management skills.Ability to manage multiple priorities within a fast-paced global environment.Preferred Qualifications:Experience supporting filtration, purification, laboratory, bioprocessing, diagnostics, medical device, pharmaceutical, or chemical products.Knowledge of global chemical regulations including TSCA, REACH, GHS, CLP, RoHS, PFAS, Food Contact, and Hazard Communication requirements.Experience supporting New Product Introduction (NPI) and product lifecycle management.Experience performing product risk assessments and lifecycle evaluations.Knowledge of ISO 9001, ISO 13485, and quality management systems.Experience preparing Safety Data Sheets (SDS), regulatory declarations, and customer compliance documentation.Regulatory Affairs Certification (RAC), Certified Hazardous Materials Manager (CHMM), or other applicable professional certifications.Competencies:Successful candidates demonstrate:Strong scientific and technical judgment.Excellent problem-solving and risk assessment skills.Customer-focused decision making.Ability to influence without authority across global organizations.Strong collaboration and relationship-building skills.Effective communication with technical and non-technical audiences.Continuous improvement mindset.Ability to balance compliance, innovation, and business objectives.Comments: - Virtual interview, Monday thru Friday, 8:00-5:00, Can be flexible on work hours, Hybrid on site
- ...Regulatory Affairs Specialist IIIVARITE is looking for qualified Regulatory Affairs Specialist III in Maplewood, MN.An American-headquartered life science and clinical research company. It is a global supplier of analytical instruments, clinical development solutions,...Suggested
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...Regulatory Affairs Specialist III Our client, a leading organization in the life sciences and healthcare industry, is seeking a Regulatory Affairs Specialist III to join their team. As a Regulatory Affairs Specialist III, you will be part of the Regulatory Affairs &...SuggestedWeekly payTemporary workFlexible hours$89.83k - $170.21k
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- ...Regulatory Affairs Specialist II - (RAS2.1) Company Description Stereotaxis is the global leader in innovative robotic technologies designed to enhance... ...highly preferred. Knowledge of global Class I, II and/or III hardware/software/sterile medical device requirements....SuggestedWork at office
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...Regulatory Operations Specialist IAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices...For contractorsWork experience placementWorldwideShift work- .... • Conduct evaluations of chemical formulations to support regulatory compliance determinations. • Administer regulatory label and... ...Policy: Skills and Requirements • 4+ years of Regulatory Affairs experience in a corporate environment • Bachelor's degree with...
- ...Regulatory Affairs Specialist This role is ideal for a regulatory professional with strong experience in FDA, Health Canada, and EU medical device requirements. The Regulatory Affairs Specialist will maintain global registrations and technical documentation, support...Work at office
- ...Brands, the parent company of Orangetheory, Anytime Fitness, Waxing the City, and The Bar Method, is seeking a Technical Project Manager III to lead cross-functional initiatives in our In Studio Engineering domain, which powers the in-studio technology experience across...Work experience placementLocal areaShift work
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...to inspire as we engineer the extraordinary. The Principal Regulatory Affairs Specialist will play a key role in launching new products and sustaining... ...that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.Physical Job RequirementsThe above...Full timeH1bWork at officeLocal areaImmediate startWorldwideFlexible hours$92k - $138k
...provide. Therefore, we are looking for a passionate Senior Regulatory Affairs Specialist who has direct experience submitting regulatory submissions... ...experience in the medical device industry, particularly with Class III medical devices (PMA). Regulatory Submission Expertise:...Full timeH1bLocal areaImmediate startWorldwideFlexible hours- ...Principal Regulatory Affairs Specialist The Principal Regulatory Affairs Specialist is responsible for developing and implementing regulatory strategies across projects, processes, and/or products. This individual partners with internal stakeholders and external consultants...Worldwide
- ...Senior Regulatory Affairs SpecialistWe are seeking a Senior Regulatory Affairs Specialist to join one of our leading healthcare clients.Position Overview:Submission Readiness & Execution. Provide Regulatory Affairs support for multiple global submissions by coordinating...Work at office
- ...fully remote and hybrid career options; so, when you work for Northteq, you can work from anywhere! POSITION SUMMARY The Project Manager III is a mid-level role. You will lead Northteq teams through the implementation of our loan/lease origination software. In this role,...Permanent employmentFull timeCasual workWork at officeImmediate startRemote workMonday to Friday
$61.3k - $122.7k
...The Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN. In this role,... .... Review and approval of manufacturing changes for Class III implantable medical devices. Support regulatory projects by...Work at officeShift work$107.9k - $179.9k
...technology who wants to work in a collaborative environment? As an experienced Senior Data Product Analyst - Data Management Engineer III, you will have the opportunity to share new ideas and collaborate on projects as a consultant without the extensive demands of travel...Local areaVisa sponsorship- Job Description: Highly experienced Principal Regulatory Affairs Specialist to lead and support global post-market regulatory compliance activities within the Interventional Cardiology and Vascular Therapies Division. This role is responsible for ensuring compliance with...
$107.2k - $160.8k
...font-size: 30px; font-weight: bold; width: 883px; left: 5px; height: 72px; padding-left: 17px; padding-top: 15px; } he Regulatory Affairs Specialist is responsible for day-to-day regulatory affairs tasks required to maintain compliance with Coloplast’s quality system and...Work at officeLocal areaImmediate startFlexible hours$72k - $80k
...annuallyJOB SUMMARY: Catholic Charities is seeking a culturally responsive, trauma-informed, dynamic, and self-motivated Program Manager III to serve in a high-level, flexible leadership role. This position will provide program management support across multiple Catholic...Full timeContract workFlexible hoursShift work$105.63k - $130.49k
...level. We are more than products, we are a team of inspired people doing extraordinary things.YOUR OPPORTUNITYAs the Financial Analyst III/Sr. Financial Analyst you will support a growing custom manufacturing business by driving strategic financial analysis, operational...Full timeWork at officeWorldwide- ...The Science Team at Pride Health is hiring a "Regulatory Specialist" for a top materials science company. Key Responsibilities Manage U.S. product... ...regulated products. Collaborate with global Regulatory Affairs teams to facilitate regulatory submissions and approvals. Prepare...
- ...Regulatory Affairs Consultant (Contract-to-Hire) We are seeking a Regulatory Affairs Consultant for a 6-month contract-to-hire opportunity supporting Class II medical devices, with a strong focus on SaMD. 6-month contract-to-hire 40 hours per week Hybrid: 2–3 days onsite...Contract work
$72k - $80k
...Are you passionate about creating opportunities for people to thrive? Catholic Charities is the place for you! Program Manager III Elliot Park - Float The mission of Catholic Charities is to serve those most in need and to advocate for justice in the community...Full timeContract workFlexible hoursShift work- ...Our client, a leader in the healthcare industry, is seeking a Regulatory Affairs Specialist to join their team. As a Regulatory Affairs Specialist, you will be part of the Regulatory Affairs Department supporting global post-market compliance activities. The ideal candidate...Weekly payTemporary workFlexible hours
$85k - $104k
...policies. ESSENTIAL FUNCTIONS OF THE POSITION: Support global regulatory pre-market applications for geographies included but not limited... ...applicable regulations (Change Control) Work with Regulatory Affairs staff, engineers and technical experts to resolve potential...Contract workTemporary workFor contractorsFor subcontractorWork at officeLocal areaRemote workWorldwide$52k - $101k
...users and training purposes.Develops operational procedures for products, services and systems supported.Designs processes to meet regulatory requirements.Develops and generates specialized and ad hoc reports.Analyzes reports and makes recommendations for improvements in...Full timeH1bWork at officeRemote workWork from homeFlexible hours- ...company strategic objectives. Responsibilities Identify opportunities to increase efficiency, improve service levels and to ensure regulatory compliance through enhanced operations Develop strategies to realize improvement opportunities, and ensure organizational...Full timePart timeWork at officeRemote workFlexible hours
- Medtronic plc busca un Especialista en Asuntos Regulatorios para desarrollar estrategias de registro mundial y apoyar la presentación de expedientes ante agencias regulatorias como FDA y EU MDR. Se requiere experiencia en dispositivos médicos, conocimientos de normativas...
- ...reporting, and employee inquiries. This position offers the opportunity to work directly alongside an experienced Labor Compliance Specialist and develop into a subject matter expert over time. This role is ideal for someone with experience in construction payroll,...Contract workTemporary workWork at officeLocal areaMonday to Friday
- Henry Schein, Inc. seeks an experienced EHS professional to develop and maintain policies and programs across warehousing and manufacturing operations in Minnesota. You will perform on-site inspections, support incident investigations, and ensure OSHA and DOT compliance...
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