Regulatory Affairs Specialist II - IVDR & Submissions
ProKatchers LLC
ProKatchers LLC is seeking a Regulatory Affairs Specialist II in South Portland, ME. This role involves technical writing in compliance with In Vitro Diagnostic medical device Regulation (IVDR) and providing regulatory support for diagnostic product development. The position requires a strong understanding of regulatory strategies to achieve product clearance in the EU and globally. Candidates must hold at least a High School diploma with experience in regulatory affairs being a plus. #J-18808-Ljbffr ProKatchers LLC
- ...pharmaceutical company is seeking a Regulatory Affairs Specialist II to prepare documentation for EU Technical... ...Affairs, particularly with IVDR and EU regulations. Key responsibilities... ...for product development, compiling submission documents, and maintaining approvals...Suggested
- ...life sciences company in South Portland, Maine is seeking a Regulatory Affairs Specialist II to prepare documentation for EU Technical Files and... ...experience in Regulatory Affairs and a strong understanding of IVDR and EU regulations. Key responsibilities include developing...SuggestedWork at office
- Overview The position of Regulatory Affairs Specialist II is within the companies Infectious Disease business... ...medical device Regulation (IVDR). Provides regulatory support for diagnostic... ...regulatory teams to assist with submissions, license renewals, and license amendments...SuggestedWork at office
- ...We are pleased to offer an exciting opportunity for a Regulatory Affairs Specialist to work in a hybrid capacity from one of our offices in Arkansas... ...Coordinates, prepares, and reviews regulatory submissions to assure rigor, accuracy, and clarity of presentation and...SuggestedWork experience placementWork at officeLocal areaRemote workWork from home
- Principal Quality & Regulatory Specialist We are seeking a Principal-level Quality and Regulatory Affairs professional to lead and support global regulatory... ...house expert on global IVD regulatory submissions, including FDA 510(k), EU IVDR, Health Canada, APAC, and other...SuggestedFull time
- ...Utilities We are pleased to offer an exciting opportunity for a Regulatory Affairs Specialist to work in a hybrid capacity from one of our offices in... ...from legal reviews and research to preparation and submission of regulatory filings. The role requires developing analysis...Work experience placementWork at officeLocal areaRemote work
$61.68k - $92.52k
...Business Analyst II - Wellpoint Federal Location : This role requires associates to be in-office 1-2 days per week, fostering... ...understanding of Part A and/or Part B claims workflows, including regulatory requirements, CMS guidance, and CR/TDL implementation processes....Temporary workWork experience placementWork at officeLocal area2 days per week1 day per week$29.75 - $47.75 per hour
...Enabling Functions Job Description: The Business Analyst II provides support and delivery of requirements and work packages... ...Management/work packages for Tier 5 low to moderate risk and regulatory projects or initiatives and may contribute to Tier 3-4 projects...Work at officeLocal areaWork from homeFlexible hours$73.3k - $150.5k
...those who challenge the status‑quo. Unum is changing, and we’re excited about what’s next. Join us. General Summary Business Analyst II - IT are responsible for working with the agile team and the Product Owner to define and document acceptance criteria with little to...Temporary workWork at office- A leading technology firm located in Portland, ME is seeking a Program Manager II for product development. This role entails overseeing project timelines and budgets while improving product quality and processes. The ideal candidate will have 2-5 years of relevant experience...
- Program Manager II, Product Development page is loaded## Program Manager II, Product Developmentlocations: Portland, MEtime type: Full timeposted on: Posted Yesterdayjob requisition id: REQ107082Join EnviroLogix and you’ll be a part of a team that is pushing diagnostic...Temporary workWork at office
- Summit Utilities is seeking a Regulatory Affairs Specialist to support regulatory work, including legal reviews and submissions. This role involves preparing materials for regulatory leadership, coordinating responses, and managing regulatory processes. Candidates should...
- A leading IT staffing company is seeking a Business Systems Analyst II for a key role with a major bank to enhance risk modeling processes. This position, based in South Portland, involves managing and analyzing data to support model development and validation in a compliance...
- ...Manager II, Codes and Standards Join our growing team and see why Summit Utilities, Inc was named as one of the Fastest Growing... ...Senior Manager serves as a key advisor to senior leadership on regulatory risk, natural gas codes and standards, and the impact of emerging...Work experience placementWork from home
- Premiere Healthcare Staffing is seeking a Radiology Technologist II for an assignment in Bridgton, ME. This role involves... ...Clinical Radiography. The position offers flexible shifts and support from career specialists. #J-18808-Ljbffr Premiere Healthcare StaffingFlexible hours
- Northern Light Health is seeking a Registered Nurse II for the Wound Clinic in Portland, Maine. This per diem role involves delivering patient care, supervising staff, and assessing patient needs. The role requires a strong understanding of nursing principles and the ability...Daily paid
- ...why Martin's Point has been certified as a "Great Place to Work" since 2015. Position Summary The Business Support Specialist works collaboratively with the entire Support Services team to provide a variety of support related services and is responsible for...Work experience placementLocal area
- LANCO Integrated in Westbrook, Maine is looking for an Automation Manufacturing Project Leader II to lead the commissioning and assembly of custom automation systems. The ideal candidate should possess mechanical expertise, strong leadership skills, and have an A.S. degree...
$45k - $50k
...due date Issues final data packages State reporting forms and submission DMR forms EDD checkers Data upload Compiles case narratives... ...status in LIMS Essential Duties and Responsibilities for Analyst II Performs laboratory procedures requiring knowledge of...Full timeContract workWork at officeMonday to FridayDay shift$73.3k - $150.5k
COMFORT SYSTEMS is seeking a Business Analyst II - IT in Portland, Maine, to define and document acceptance criteria, ensuring high-quality software solutions. Candidates should have a Bachelor’s Degree (preferred) and 4+ years of agile team experience. Key responsibilities...- ...Portland, ME. This role involves managing wastewater infrastructure projects across the Northeast, ensuring adherence to technical and regulatory requirements. Candidates should have a Bachelor’s degree in Civil or Environmental Engineering, a Professional Engineer license,...
$63.44k - $95.16k
A leading grocery retailer is seeking an Analyst II to enhance Supply Chain visibility and efficiency. This role requires a Bachelor's degree in a related field and 1-4 years of relevant experience, with strong analytical skills. The position offers a hybrid work schedule...Work at officeRemote work$105.79k - $141.05k
Lumen is the trusted network for the AI‑powered world, connecting people, data, and applications through our expansive fiber network and connected ecosystem. We enable secure, high‑performance connectivity across cloud, edge, and AI workloads for enterprises, governments...Full timeTemporary workFor contractorsRemote work$63.44k - $95.16k
Ahold Delhaize USA is seeking a Supply Chain Analyst II in Scarborough, Maine. The role requires delivering analytics for supply chain consistency and reliability, with the necessity for a Bachelor’s degree in a related field and 1-4 years of experience. Proficiency in...Work at officeFlexible hours$63.44k - $95.16k
...in support of Supply Chain consistency and reliability, as well as providing needed reporting in support of S&OP processes. Analyst II supports Supply Chain reporting in an assigned region and performs all principal duties described herein. Additionally, this role may...Full timeWork at officeRemote workFlexible hours$75.04k - $112.56k
...delivery of program support to meet both internal and external regulatory expectations. Work Schedule and Eligibility Our flexible/... ...processes, and conflict-of-interest program, including the review of submissions and comprehensive reporting within the US. Support the Speak...Full timeWork at officeLocal areaRemote workFlexible hours$71k - $125k
...Governance, Controls, and Documentation* Document investment processes, controls, and oversight routines for RCSAs, audits, and regulatory needs.* Coordinate issue logs, exceptions, and remediation plans from CIO‐owned processes.* Ensure governance forums receive clear...Odd jobWork experience placementWork at officeFlexible hoursNight shift$75.04k - $112.56k
Hannaford Supermarkets in Scarborough, Maine, is seeking an Ecommerce Strategy Specialist II to enhance their eCommerce strategy and fulfillment execution. This role requires a strong background in ecommerce operations, experience in coordinating cross-functional teams,...- Title : QA Specialist II Location : Scarborough, Maine Duration : 9 Months 100% Onsite Qualifications 3+ years prior experience in a Quality Assurance role or similar support role in the medical device industry. Minimum three years in a Quality Assurance role for manufacturing...Temporary workFlexible hours
- MaineHealth is seeking a Patient Safety Specialist II to support patient safety and clinical risk management across its healthcare system. This role involves investigating safety events, collaborating with clinical leaders, and educating teams on best practices in risk...
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