EU Regulatory Strategist: IVDR Writing & Submissions
ProKatchers LLC
A leading medical device firm located in South Portland, Maine, seeks a Regulatory Specialist to oversee technical writing and regulatory strategies for In Vitro Diagnostic products. The role involves supporting product development, managing submissions, and ensuring compliance with EU regulations. Ideal candidates should have experience in regulatory affairs, particularly with IVDR, and strong analytical skills to navigate the complexities of medical device regulations. #J-18808-Ljbffr ProKatchers LLC
- ...pharmaceutical company is seeking a Regulatory Affairs Specialist II to prepare documentation for EU Technical Files and... ...Regulatory Affairs, particularly with IVDR and EU regulations. Key responsibilities... ...product development, compiling submission documents, and maintaining...Regulatory
- ProKatchers LLC is seeking a Regulatory Affairs Specialist II in South... ...This role involves technical writing in compliance with In Vitro Diagnostic... ...medical device Regulation (IVDR) and providing regulatory... ...achieve product clearance in the EU and globally. Candidates must...Regulatory
- ...sciences company in South Portland, Maine is seeking a Regulatory Affairs Specialist II to prepare documentation for EU Technical Files and international product... ...Regulatory Affairs and a strong understanding of IVDR and EU regulations. Key responsibilities include developing...RegulatoryWork at office
- Responsible for technical writing of files in accordance with... ...medical device Regulation (IVDR). Provides regulatory support for diagnostic product... ...clearance/approval in the EU and internationally.... ...regulatory teams to assist with submissions, license renewals, and license...Regulatory
$80.6k - $145k
Senior Medical Writer - Regulatory Documents - CSR /Protocol - Late Phase... ...completion of medical writing deliverables, ensuring scientific... ...development plans; IND submissions; integrated summary reports;... ...including the implementation of the EU Equality Directive, in...RegulatoryContract workFlexible hours$80.6k - $145k
...accurate completion of medical writing deliverables, ensuring... ...clinical development plans; IND submissions; integrated summary reports;... ...meetings. Adheres to established regulatory standards, including, but not... ...the implementation of the EU Equality Directive, in...RegulatoryContract workFlexible hours- Principal Quality & Regulatory Specialist We are seeking a Principal-level Quality and Regulatory Affairs professional... ...Serve as the in-house expert on global IVD regulatory submissions, including FDA 510(k), EU IVDR, Health Canada, APAC, and other international markets....RegulatoryFull time
$96k - $181k
...Sr Fiduciary Strategist Location: 200 Middle Street, Suite 301, Portland Maine The Sr Fiduciary Strategist is responsible for fulfilling... ...adherence to all internal fiduciary policies and procedures, regulatory and legal requirements. Assumes accountability for all...RegulatoryWork experience placementWork at officeLocal areaFlexible hours$90.1k - $153.3k
...devices in compliance with applicable regulatory and quality system requirements. The ideal... ...issues outside of current technical writing knowledge and capability and selects the... ...with global labeling requirements (FDA, EU MDR, IVDR, Health Canada, etc). Experience...RegulatoryHourly payTemporary workMonday to FridayFlexible hours$119k - $210k
...compensation and/or No Fault law. Exceptional legal research, writing, negotiation, and analytical skills. Proficient in advanced e-... ...Commitment to ethical legal practice and compliance with all regulatory and professional standards. About Us Pay Philosophy: The typical...RegulatoryFull timeLocal areaRemote workFlexible hours- ...is seeking a dedicated and highly organized Sales Compensation Strategist to provide exceptional administrative support to the Division... ...accurate execution. Ensure compliance with company policies and regulatory requirements. Address and resolve compensation-related...RegulatoryFor contractorsWork at officeLocal area
$165k - $220k
...health in the future. The Director, Regulatory Affairs leads global regulatory strategy... ...interactions, ensure highquality submissions, and manage regulatory risk across the... ...Excellent communication, organizational, and writing skills, with strong attention to detail...RegulatoryTemporary workWork visa- ...being at the forefront of evolving industry trends and fast‑paced regulatory changes. We regularly defend employers against discrimination,... ..., ideally within employment law Strong legal research, writing, and analytical skills Experience drafting pleadings, motions...RegulatoryWork at office
- ...and treatment delivery models to ensure care meets clinical and regulatory standards Deliver care that aligns with treatment goals and... ...within the facility Demonstrate proficiency in reading, writing, speaking, and understanding English for effective communication...RegulatoryFull timeContract workReliefFlexible hours
- ...and treatment delivery models, ensuring care meets clinical and regulatory standards. • Follow infection control and environmental... ...within the facility. • Demonstrate proficiency in reading, writing, speaking, and understanding English for effective communication...RegulatoryFull timeContract workReliefFlexible hours
$71k - $125k
...processes, controls, and oversight routines for RCSAs, audits, and regulatory needs.* Coordinate issue logs, exceptions, and remediation... ...challenges.**Core Competencies*** Strong analytical and writing skills* Understanding of investment vehicles, governance processes...RegulatoryOdd jobWork experience placementWork at officeFlexible hoursNight shift- ...to offer an exciting opportunity for a Regulatory Affairs Specialist to work in a hybrid capacity... ...reviews and research to preparation and submission of regulatory filings. The role requires... ...and regulatory concepts. Strong writing and research skills, with the ability to...RegulatoryWork experience placementWork at officeLocal areaRemote work
- ...system and serves as liaison to external agencies relative to regulatory compliance and language access. The Director develops and implements... ...Demonstrates a strong ability to communicate verbally and in writing to internal and external constituencies. # Established...RegulatoryWork at officeImmediate startFlexible hours
$72.28k - $108.16k
...effectiveness of operational procedures and controls related to regulatory compliance within business units of TD Bank and its affiliates... ...be discussed with the business lines Assists management in writing findings as applicable to address areas of improvement...RegulatoryWork experience placementWork at officeLocal areaWork from homeFlexible hours$80k - $95k
...communities? Verdantas is seeking a Municipal Funding & Grant Strategist to support the growth of our government and municipal... ...applications for municipal or infrastructure-related projects ~ Strong writing and communication skills, with the ability to translate...Temporary workWork at officeFlexible hours$1,300 per day
...own and the client schedule Utilize your regulatory knowledge of various standards from ISO,... ...regarding edits/questions to your audit report Write audit reports in accordance with client... ...audit experience to 21 CFR part 210/211, EU Vol 4, ISO 13485, 21 CFR part 820, Canada...RegulatoryContract workLocal areaRemote workWorldwide$82.5k - $110.5k
...across New England. This role emphasizes permitting strategy, regulatory compliance, and agency coordination for transportation, coastal... ...reviews through approval. Strong communication and technical writing skills, including client‑facing interaction and regulatory...RegulatoryWork at officeLocal area- ...working group/project teams* Possesses an understanding of the regulatory landscape and requirements, ensuring they are identified and... ...problems involving standardized situations - Continuous* Reading, writing and comprehending instructions - Continuous* Adding,...RegulatoryWork experience placementWork at office
$185k - $220k
...with commercial, clinical development, regulatory teams and internal stakeholders. Maintain... ...development opportunities. Responsible for writing and/or review of relevant Standard... ...interpret FDA 505(b)2, 505(b)1, 505 (j) submission requirements. Knowledge of PC systems and...RegulatoryPermanent employmentWork at officeNight shift$140k - $165k
...Interfacing with state and local regulatory agencies and permitting officials... ...laws and funding programs. ~ Excellent writing, communication, and presentation skills... ...unsolicited resumes from recruitment agencies. Submissions without a signed agreement in place will...RegulatoryHourly payContract workTemporary workFor contractorsFor subcontractorLocal area$100k - $165k
...Documents. Interfacing with state and local regulatory agencies and permitting officials... ...equipment, and processes. ~ Superior writing, communication, and presentation skills... ...resumes from recruitment agencies. Submissions without a signed agreement in place will...RegulatoryHourly payContract workTemporary workFor contractorsFor subcontractorWork at officeLocal areaRemote workFlexible hours- ...we do. We are pleased to offer an exciting opportunity for a Regulatory and Rates Analyst to work in a hybrid capacity from one of our... ...natural gas industry or regulated utility desirable Professional writing abilities required KNOWLEDGE, SKILLS, ABILITIES Solid...RegulatoryWork experience placementWork at officeRemote workWork from home
- ...specifications. Construction administration. Technical writing and communications with clients and regulatory authorities. Mentoring and delegating to staff-... ...we do not accept unsolicited resumes or candidate submissions from recruitment agencies. Any resumes or...RegulatoryContract workTemporary workLocal area
$89k - $146.9k
...developing procedures and permits, preparing and submitting periodic regulatory reports, and preparing and delivering environmental training... ...with company policies. Moderate proficiency with business writing, office automation and communication software, technology, and...RegulatoryWork at officeLocal areaNight shift- ...improvement at the staff, team, and agency level regarding outcome and regulatory compliance. The Clinical Assurance Specialist assists with... ...effectively. Effectively Communicates: Listens, speaks and writes appropriately, using clear language. Communication methods are...RegulatoryFull timeWork experience placementFlexible hours
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