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
$78k - $100k
2026-08-21 Daimler Truck North America LLC Regulatory Affairs Specialist II Inside the Role Join DTNA's Trade Compliance team and play a key role... ...entry discrepancies and support corrective actions. Monitor submission status and assist with resolving ACE filing errors, CBP...SuggestedTemporary workFor contractorsWork at officeLocal areaRemote workRelocationHome officeRelocation package- ...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
- ...Job Title : Regulatory Affairs Specialist II Location : South Portland, ME 04106 Duration : 08 Months Education... ...medical device Regulation (IVDR). Provides regulatory support for diagnostic... ...regulatory teams to assist with submissions, license renewals, and license...Suggested
- Daimler Truck North America LLC in Portland, OR is seeking a Regulatory Affairs Specialist II to support import compliance, duty recovery, and post-entry corrections. You will help ensure CBP requirements are met and contribute to continuous improvement of the trade compliance...Suggested
- Experis is seeking a Regulatory Specialist I to join our team onsite in South Portland, Maine. You will compile documentation for submissions, assist with regulatory research, and maintain licenses and approvals for marketed products. The role requires a Bachelor’s degree...
- Experis is seeking a Regulatory Affairs Associate to join our team in South Portland, ME, onsite only. The role focuses on assisting in the development and submission of product registration documentation, coordinating regulatory submission packages, and maintaining global...
- Daimler Truck North America LLC is seeking a Post Entry Corrections Analyst II to join the Trade Compliance team in Portland, OR. You will identify opportunities to improve customs compliance, recover duties, and ensure import transactions meet CBP requirements, working...
- TD Bank is seeking an HR Program Analyst II for our Mount Laurel, NJ location. You will perform broad HR program analytics, develop processes, and monitor initiatives across HR systems to drive data-informed decisions. Ideal candidates have 2+ years of relevant experience...
$105k - $115k
...Project Manager II The Project Manager II is a mid-level leadership role responsible for developing, managing, and executing the university's annual Capital Additions, Replacements, and Renewals (CARR) program as well as ongoing Capital Construction projects as needed...For contractorsH1bFlexible hours- ## Project Manager II - StructuresApplylocations: South Portland, ME (Portland): Bedford, NHtime type: Full timeposted on: Posted Todayjob requisition id: R-29377**What We're Looking For**Our growing team is seeking an experienced, and technically sound Project Manager...Contract workWork at officeVisa sponsorship
- 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...Full time
- ...Job Title: Regulatory Affairs Associate Location: South Portland, ME - 100% Onsite Pay Range: $21/hr on W2 Job Details: Assist in the development and submission of product registration documentation Coordinate and prepare regulatory submission packages...Weekly payTemporary workFlexible hours
- ...Title: Regulatory Affairs Associate Location: South Portland, ME Duration: 12 Months Shifts: 8AM TO 4:30PM 100% Onsite Main... ...knowledge in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience...Temporary workFlexible hoursShift work
- HNTB Corporation is seeking a Project Manager II to oversee exciting bridge projects in Portland, ME. The role involves managing project scope, budgets, and schedules, while leading a team of engineers and ensuring quality deliverables. The ideal candidate will have at...Full time
- The Indirect Sourcing Analyst II at Ahold Delhaize USA is a key contributor to our strategic sourcing organization, driving cost optimization across a $5B Not For Resale spend. You will support strategic planning and lead tactical execution, aligning with business goals...Remote work
$21.54 - $30.14 per hour
...Currently, this position is not eligible for visa sponsorship or STEM OPT extensions. Core Responsibilities: As an Eligibility Specialist II, you’ll play a vital role in connecting Maine residents to key programs including MaineCare—the state’s largest health insurance...Hourly payFull timeTemporary workSeasonal workWork at officeImmediate startRemote workFlexible hours- ...Title: Regulatory Specialist I Location: South Portland, ME Duration: 12 Months Shift:... ...product-development/support, or scientific affairs function. ~ Bachelor's Degree in... ...and teams. Prepares U.S. regulatory submissions and/or registration documents for...Temporary workWorldwideFlexible hoursShift work
$63.44k - $95.16k
...Finance, Legal, Sustainability, Commercial, Digital and E-commerce, Technology and more. The Master Data Management Support Analyst II plays a critical role in all vendor and item set-up and maintenance activities across Ahold Delhaize USA. This position involves collaborating...Work experience placementWork at officeLocal areaRemote workFlexible hours$63.44k - $95.16k
...Finance, Legal, Sustainability, Commercial, Digital and E-commerce, Technology and more. The Master Data Management Support Analyst II plays a critical role in all vendor and item set-up and maintenance activities across Ahold Delhaize USA. This position involves collaborating...Work experience placementWork at officeRemote workFlexible hours- Ahold Delhaize USA is seeking a Master Data Management Support Analyst II to manage vendor and item set-up across our U.S. divisions. The role emphasizes collaboration with suppliers and internal teams to ensure accurate master data and strong controls. The position supports...Work at officeRemote work
- Ahold Delhaize USA is seeking a Master Data Management Support Analyst II to manage vendor and item set-up across our brands, ensuring controls and data integrity. The role supports relationships with suppliers and internal teams, with a hybrid schedule including 3 in-...Remote work
- Job Title: Regulatory Specialist I Location: South Portland, Maine - 100% Onsite Pay Range: $24 to $28/hr on W2 Compile and publish all material required for submissions, license renewals, and annual registrations. Assist in researching scientific and regulatory information...Weekly payTemporary workWork at officeFlexible hours
- Department of Health and Human Services (DHHS) in Portland, Maine, seeks an Eligibility Specialist II to connect Maine residents with essential programs and determine eligibility with accuracy. The role emphasizes customer service, problem solving, and teamwork in a fast...
- Description Professional - Nonclinical Req #: 69174 Summary The Vocational Services Employment Specialist II role provides support to individuals with disabilities in jobs in their communities. This includes training individuals in job tasks, job coaching, assessing progress...Daily paid16 hoursImmediate startFlexible hours
- What We're Looking For Our growing team is seeking an experienced, and technically sound Project Manager to work on some of the region’s most exciting bridge projects. The ideal candidate will be motivated to grow client relationships in Maine, New Hampshire, and Vermont...Full timeContract workPart timeWork at officeImmediate startVisa sponsorship
- HNTB seeks a skilled Project Manager to oversee exciting bridge projects in South Portland, Maine. The ideal candidate will manage project budgets, schedules, and lead a dedicated engineering team. This role involves fostering client relationships and ensuring project delivery...
- Portfolio Compliance AnalystA Portfolio Compliance Analyst is needed to oversee and monitor Fund post-trade compliance with prospectus and other portfolio requirements. The Portfolio Compliance Analyst will identify and set-up monitoring rules, oversee or effect data imports...
$38.38k - $76.65k
...for diversity, working mothers, female executives, and scientists The Opportunity We have an opportunity for Production Specialist II based in Scarborough, ME. In this role, you will perform the work required for the assembly of components, devices, and/or the...Full timeShift workAfternoon shift$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
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Specialist II - IVDR & Submissions. Be the first to apply!
- regulatory affairs specialist South Portland, ME
- medicare compliance specialist South Portland, ME
- regulatory compliance analyst South Portland, ME
- compliance specialist South Portland, ME
- aml compliance analyst South Portland, ME
- regulatory officer South Portland, ME
- healthcare compliance officer South Portland, ME
- regulatory analyst South Portland, ME
- regulatory specialist South Portland, ME
- compliance associate South Portland, ME

