Regulatory affairs specialist
Creative Solutions Services, LLC
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 global regulatory requirements related to product incident reporting, corrective and preventive actions (CAPA), recalls, field actions, audits, and post-market surveillance activities. The ideal candidate will possess deep knowledge of U.S. and international medical device regulations, strong analytical capabilities, and the ability to collaborate effectively across cross-functional teams to drive compliance and continuous improvement initiatives. Responsibilities Lead regulatory activities supporting product corrections, recalls, and field actions. Partner with internal global regulatory teams and external regulatory authorities regarding recall-related communications and submissions. Manage Product Incident Reports (PIRs), including investigation, risk assessment, documentation, and regulatory reporting. Drive development, implementation, and monitoring of CAPAs to address nonconformances and improve regulatory processes. Support internal and external audits, inspections, and compliance assessments. Ensure compliance with FDA regulations, EU MDR requirements, and other international regulatory frameworks. Monitor evolving global regulatory requirements and communicate regulatory updates to stakeholders. Provide regulatory guidance for post-market surveillance and quality-related activities. Develop and deliver regulatory compliance training to internal teams. Collaborate with Quality, Clinical, Engineering, Manufacturing, and Commercial teams to ensure regulatory compliance throughout the product lifecycle. Requirements Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or a related scientific/technical discipline, along with 12+ years of relevant industry experience. Minimum 5 years of experience in Regulatory Affairs and/or Quality within the medical device, healthcare, or life sciences industry. Minimum 2 years of direct Regulatory Affairs experience. Strong knowledge of U.S. FDA regulations and medical device regulatory requirements. Experience managing Product Incident Reports (PIRs). Corrective and Preventive Actions (CAPAs). Product recalls and field corrective actions. Audit and inspection support activities. Experience using regulatory systems, databases, and documentation tools. Strong written and verbal communication skills. #J-18808-Ljbffr Creative Solutions Services, LLC
$107.2k - $160.8k
...he Regulatory Affairs Specialist is responsible for day-to-day regulatory affairs tasks required to maintain compliance with Coloplast’s quality system and applicable regulatory requirements. This position will also prepare, monitor, and communicate status of regulatory...SuggestedWork at officeLocal areaImmediate startFlexible hours- Job Title: Regulatory Affairs Specialist II Location: Minneapolis, MN 55401, US (Primary) Education: Bachelor's Degree Career Level: Experienced (Non-Manager) Category: Regulatory and Compliance Job Type: Full-time Position Summary The Regulatory Affairs Specialist...SuggestedFull timeWork at office
- Regulatory Affairs Specialist - International REMOTE Reports to: Manager, Regulatory Affairs Summary The Regulatory Affairs Specialist, International plays a key role in supporting our client’s global regulatory strategy by helping prepare and maintain submissions, registrations...SuggestedContract workWork at officeRemote work
$120.49k - $192.78k
Principal Regulatory Affairs SpecialistJoin RespirTech's team in Plymouth, MN as a Principal Regulatory Affairs Specialist, where you will develop and execute global regulatory strategies for innovative airway clearance therapy devices, enhancing product development, design...SuggestedFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...understand requirements of pertinent federal, state and local regulatory schemes in reference to all business units within the organization... ...years required? Background in compliance, regulatory affairs, or similar Experience with large, complex...SuggestedLocal area
- ...Job Duties Assist CCO with review and implementation of regulatory initiatives, review and interpret rules and guidance, documentation... ...and regulatory audits/exams become proficient on regulatory/legal affairs Assist with internal audits, 3120 testing...Contract workWork at office
$60k - $90k
Job Description At Norton Rose Fulbright, people thrive because of a shared commitment to quality, unity and integrity. The highly regarded law firm consistently receives recognition from Great Place to Work and Top Workplaces, two companies that specialize in assessing...Full timeFor contractorsWork at officeRemote workWorldwideFlexible hours- ...The primary purpose of this position is to support quality assurance and regulatory compliance across all sites and services. This includes coordinating site and Individual Served Record audits, monitoring Electronic Visit Verification (EVV) compliance, completing attendance...Hourly payWork at office
- ...incident reports of theft, loss, or release of select agents, and reports of identification of select agents. When potential regulatory violations are identified at either registered or nonregistered entities, the selectee coordinates and participates in investigations...
$65k - $85k
...structural glass facades in North America. As our Compliance Specialist, you will play a critical role in supporting the continued growth... ...and documentation to support audits, legal inquiries, or regulatory reviews. Coordinate with estimating, safety, legal, risk, and...Full timeFor contractorsWork experience placementFor subcontractorWork at officeLocal areaFlexible hours$75k - $80k
...Position Summary:The HR Data & Compliance Analyst is responsible for managing and analyzing HR data, ensuring compliance with legal and regulatory requirements, and optimizing HRIS reporting processes. This role involves generating reports, maintaining data accuracy, and...Temporary workWork experience placementLocal areaRemote work$88k - $130k
Regulatory Affairs SpecialistThis is a mid-level Regulatory Affairs position responsible for integrating regulatory knowledge throughout the product lifecycle and coordinating projects effectively. The role supports the Regulatory Affairs team by communicating regulatory...Temporary workWork at officeFlexible hours- ...application due to a disability, contact this employer to ask for an accommodation or an alternative application process. Regulatory Affairs Specialist Regular Full-Time Scanlan International, Inc., St. Paul, MN, US The Regulatory Affairs Specialist will assist in...Full timeWork experience placementWork at officeWorldwide
$60k - $120k
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- ...in medical technology.\This position will be instrumental in helping VDYNE achieve these ambitious goals. THE ROLE As a Regulatory Affairs Specialist at VDyne, you'll support regulatory operations and global clinical and commercial regulatory activities across an active...Work at officeShift work
- Regulatory Affairs SpecialistWe believe that great healthcare is an essential safeguard of human dignity.At Laborie, we know the work we do... ...Technologies is currently searching for a Regulatory Affairs Specialist to join our team in a hybrid role based out of the...WorldwideFlexible hours
$70k - $80k
...Compliance Specialist Bigos Management- Corporate Office (Golden Valley, Minnesota) BIGOS MANAGEMENT IS PROUD TO BE NAMED A STAR TRIBUNE... ...and leasing processes of site files to ensure compliance with regulatory requirements, including Project-Based Section 8. This role...Contract workTemporary workWork at officeLocal area- Stratasys Ltd is seeking an Import Compliance Specialist to support global trade operations. The role ensures compliance with import/export regulations, analyzes trade data, and optimizes international shipping processes across logistics, compliance, and finance teams....
$60k - $90k
Job Description At Norton Rose Fulbright, people thrive because of a shared commitment to quality, unity and integrity. The highly regarded law firm consistently receives recognition from Great Place to Work and Top Workplaces. Teams collaborate across regions, value new...Full timeFor contractorsWork at officeWorldwideFlexible hours$60k - $90k
Norton Rose Fulbright is looking for a Compliance Analyst in Minneapolis. This role involves performing conflict checks, ensuring excellent client service, and reviewing information for accuracy. Candidates need a Bachelor's degree, one year of relevant experience, and ...Full time- Banner Engineering is seeking a Senior Trade Compliance Analyst to ensure global trade regulatory compliance, combining classification expertise with process improvement and cross‑functional collaboration. This role supports accurate trade data, efficient global operations...
- ...One Federal Solution is seeking Credentialing Specialists to support a large federal identity credentialing program. The Credentialing Specialist will perform credential enrollment, issuance, activation, inventory management, and customer support activities while ensuring...Permanent employmentFor contractorsWork experience placementWork at office
- ...Credentialing SpecialistsCredentialing Specialists will provide credentialing service and support to operate IRS credentialing sites utilizing the GSA scheduling tool to manage credentialing appointments, run reports through the USAccess system, and use credentialing equipment...Temporary workFor contractorsLocal areaShift workNight shiftWeekend work
- ...reviews of mortgage loan files to evaluate accuracy, completeness, investor eligibility, regulatory compliance, and adherence to Verus policies and procedures. The Compliance Specialist reviews loan documentation, exceptions or defects identified by the QC vendor,...Work at officeRemote work
$85k
...extending our products into new geographies and high-growth adjacent markets. Under minimal supervision, the Senior Regulatory Affairs Specialist will plan, manage and implement regulatory submissions to the U.S. Food and Drug Administration (FDA), European Union...Hourly payWork experience placementWork at officeLocal areaRelocationRelocation packageShift work3 days per week- ...Aviation Safety Program Compliance Specialist The employee is responsible for bringing diverse viewpoints together, effectively acquiring... ...aviation statutory regulations to ensure compliance. Conducts regulatory compliance reviews, outreach, staffing support, writing,...Work at office
$107.7k - $131.3k
...based attack techniques. Experience in a regulated environment subject to requirements such as PCI DSS, SOX, or aviation-sector regulatory oversight. Experience supporting operational technology or specialized business systems in addition to corporate IT....Full timePart timeWork at officeLocal areaVisa sponsorshipShift work$42.6 per hour
...Kelly is hiring for a EHS (Environmental, Health, & Safety) Specialist for a 12-month contract role at Minneapolis MN 55426 with our... ...license to operate. Manage submittal of all permit and regulatory required agency reports. Analyze and evaluate EH&S performance...Contract workTemporary workWork experience placementWork at officeLocal areaMonday to Friday$1,800 - $2,300 per month
...This role provides second‑line oversight and day‑to‑day advisory support across a wide range of business activities by translating regulatory requirements into practical guidance, executing operational compliance reviews, and producing governance‑ready documentation and...Contract work- Senior Regulatory Affairs SpecialistWork mode: Hybrid Onsite Location(s): Marlborough, MA, US, 01752 Additional Location(s): US-CA-Irvine;... ...an enthusiastic individual for a Senior Regulatory Affairs Specialist position (hybrid work mode) supporting our rapidly growing active...Work at officeLocal areaRelocation3 days per week
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