IVDR Regulatory Specialist II - EU Submissions & Strategy
RXinsider LTD.
Abbott in South Portland, ME is seeking a Regulatory Specialist II to support IVDR-focused activities across product development and compliance. The role emphasizes technical writing, regulatory submissions, and maintaining approvals for EU and international indications in a 12-month, onsite assignment. The ideal candidate will have a Bachelor’s degree in a technical field and 4+ years in regulatory affairs, with strong knowledge of IVDR and EU requirements. #J-18808-Ljbffr RXinsider LTD.
- Title: Regulatory Specialist II Location: South Portland, ME Duration... ...device Regulation (IVDR). Provides... ...Develops regulatory strategies for products in development... ...clearance/approval in the EU and internationally.... ...teams to assist with submissions, license renewals,...SuggestedTemporary workWork at officeFlexible hoursShift work
$87k - $149k
...position sits in the regulatory organization of... ...clinical regulatory strategies for next... ...indications in the US, EU, and rest of world... ...Regulatory Affairs Specialists (RAS) and international... ...of world clinical submissions for next-... ...particularly with Class III/II medical devices...SuggestedStart working todayLive inLocal areaRemote workWorldwideFlexible hours- ...Pharmaceuticals, Inc. is seeking an experienced Regulatory Affairs Manager to support global... ...-functionally to prepare high-quality submissions (INDs/CTAs/NDA components) and oversee... .... This role will guide regulatory strategy and execution for submissions, coordinate...Suggested
- Pelthos Therapeutics Inc. is seeking a Director, Regulatory Affairs to develop and lead regulatory strategies for drug development, registrations, and post-approval activities. You will manage submissions, coordinate with cross-functional teams, and serve as the main liaison...Suggested
$78k - $100k
Inside the Role As an Import Entry Review Analyst II, you will play a key role in supporting DTNA's import compliance program by helping ensure customs entry information is accurate, complete, and compliant before filing deadlines. Working closely with customs brokers,...SuggestedTemporary workFor contractorsWork at officeLocal areaRemote workRelocationRelocation package- Harba Solutions Inc. is seeking a Regulatory Affairs professional to manage end-to-end eCTD submissions, maintain regulatory documentation, and support FDA activities for marketed pharmaceutical products. You will monitor FDA and international guidelines, draft labeling...
- ...Reports to: Vice President, Regulatory Affairs & Quality... ...Regulatory Affairs Specialist to support the global... ...current and new markets (EU, Australia, Canada, South... ...regulatory submissions and technical documentation... ...determine submission strategy and requirements across...Full time
- Lyons Magnus, LLC is seeking a Regulatory Specialist II to support the Regulatory Team in developing and maintaining technical documentation for Lyons’ products. You will ensure compliance with local, state, and federal regulations and coordinate with R&D, Commercialization...Local area
$82k - $131.5k
...Overview Reporting to the Regulatory Affairs Manager, the... ...Regulatory Affairs Specialist independently leads regulatory... ...study start-up, submissions, maintenance, and... ...Affairs Specialists I and II, promotes best practices... ...activities and strategies including submissions...Full timeInterim roleWork at officeLocal areaRemote work- ...office. We are seeking a Senior Regulatory Affairs Specialist to support regulatory strategy/operations for our Software as a... ...the product lifecycle, including submission support, document management,... ...frameworks and standards, such as: EU MDR ISO 13485 IEC 62304 ISO 1497...Remote jobWork at officeLocal areaFlexible hours
$92k - $138k
...team partners across regulatory, quality, engineering,... ...Senior Regulatory Affairs Specialist supports regulatory... ...preparing regulatory submissions, maintaining regulatory... ...Responsibilities Provide regulatory strategy and guidance for... ...Device Regulation (EU MDR) compliance and CE...Permanent employmentH1bLocal areaFlexible hours$80.9k - $127.05k
What Regulatory Affairs contributes to Cardinal Health... ...writing and regulatory submissions as well as clinical research... ...implements regulatory strategies for products that... ...Regulatory Affairs Specialist supports the Medical Solutions... ...products meet U.S., EU, and international...Temporary workWork experience placementLocal areaRemote workFlexible hours- Volunteers of America Los Angeles is seeking an HR Associate II - Compliance to oversee legal, regulatory, and contract compliance within the HR function. The... ...coordinating with HR Service Teams to ensure timely submission of required documents. The ideal candidate has a...Contract work
$25k
...Working Title: 68055472 - GOVERNMENT ANALYST II The Agency for Health Care... ...operational processes, and implementation strategies designed to improve access, quality, coordination... ...supporting documentation with each submission that includes character of service (for...Work at officeLocal areaMonday to FridayFlexible hours$79.1k - $105.95k
...metrics, as well as developing insights to guide risk adjustment strategy, reporting, and pricing/forecasting efforts. The position... ...and reporting to inform risk adjustment operations, strategy, submissions, and vendor performance.* Perform or support financial metrics...Live inLocal area- ...We are seeking a Manager to join our Regulatory Affairs Strategy Oncology team. The Manager, Regulatory... ...your role: Coordinate the preparation, submission, management, and maintenance of global... ...interacting with CROs in managing ex‑US/ex‑EU CTAs towards clinical trial...
$80k - $95k
...positions become available. Job Purpose The Regulatory Affairs Specialist is responsible for coordinating and... ...product registrations, regulatory submissions, approvals, and post-market... ...requirements, including familiarity with EU Medical Device Regulation (MDR). Working...Work at officeWorldwideWeekend workAfternoon shift- ...Responsibilities Author, compile, review, and submit regulatory documents in eCTD format, including NDAs, ANDAs, DMFs, and post-approval submissions. Support FDA regulatory activities for... ...and process changes. Develop regulatory strategies for post-approval changes and provide...Work at office
$76k - $85.5k
...create a better tomorrow. Our strategy includes building teams... ...Summary: The Quality Systems Specialist II performs increasingly complex... ...Applies established procedures and regulatory principles with sound... ...requirements, including applicable FDA, EU, and international regulatory...Full timeContract workWork experience placementFlexible hoursDay shift- ...Brown is seeking a Senior Director of Regulatory & Legislative Strategy - Public Sector to join our growing... ...as a dedicated subject matter specialist. Additionally, this role serves as... ...Clause Prohibition Attestations, RxDC submissions, and TiC updates in coordination with...Contract workLocal area
- GoFundMe seeks an Analyst II to join its global Trust & Safety team, focusing on regulatory reporting and STR filings. You will interpret regulatory changes and help ensure compliance across products, policies, and communications. Responsibilities include preparing STRs...Remote job
- Daimler Truck North America is seeking an Import Entry Review Analyst II in Portland, OR. You will support our import compliance program, analyze data, investigate exceptions, and drive corrective actions with brokers and internal teams to reduce risk and improve data...
- ...Cross Blue Shield of New Jersey is seeking an Actuarial Analyst II to support actuarial analytics across ACA, Medicare Advantage, and... ..., translating data into actionable insights for risk adjustment strategy, reporting, and pricing/forecasting. The role requires a...Remote job
- JobSummary The Procurement Specialist II coordinates and performs procurement activities and processes... ...recommendations on potential sourcing strategies, including framework agreements or... ...knowledgeofvariousdonorprocurementregulations(e.g.USAID,EU,UN) Working...Contract workRemote work
$170k - $185k
...mission as our next Senior Regulatory Affairs Manager. This role... ...Reviews and approves U.S. and IVDR regulatory submissions. Interacts with regulatory... ...and establishes regulatory strategy to achieve market clearance... ...registrations, and EU technical documentation files...Work experience placementWork at officeLocal areaRemote workWorldwideHome officeNight shift- ...Environmental Health & Safety (EH&S) Specialist II is an experienced professional-level role... ...assigned EH&S programs to ensure regulatory compliance, operational risk reduction... ...data, training records, and regulatory submissions within assigned scope. Partner with operations...Temporary workFor contractorsWork at officeLocal areaImmediate startFlexible hoursShift workWeekend workEarly shift
- ...will conduct US domestic and international regulatory compliance activities for Lincoln... ...including regulatory change requests and submission action requests. This will include Outline... ...a thorough knowledge of APHIS/USDA/FDA/EU regulatory requirements associated with...Casual workLocal areaDay shift
- Senior Regulatory Affairs Specialist - Medical Devices Clinical San Diego , California Contract Aug 10... ...assessments and U.S. medical device submissions . This individual will serve as a regulatory... ...and implementation of regulatory strategies for new and existing products....Contract work
- ...Laboratories in Buffalo Grove, IL is seeking a Regulatory Affairs Specialist III to support regulatory direction... ...controls, prepare US regulatory submissions, and provide regulatory input to... .... The role emphasizes regulatory strategy, documentation, and collaboration with...
- The Tucson Police Department is seeking a Housing Specialist II to manage Housing Choice Voucher (HCV) and Public Housing programs. You will process applications, conduct recertifications, verify income and allowances, and handle high-volume caseloads with accuracy and...
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