EU Regulatory Strategist: IVDR Writing & Submissions
ProKatchers
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
- ...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
- ...Overview The position of Regulatory Affairs Specialist II... ...prepare documentation for EU Technical Files and... ...Responsible for technical writing of files in accordance... ...device Regulation (IVDR). Provides regulatory support... ...teams to assist with submissions, license renewals, and...RegulatoryWork at office
- ...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
- ...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
$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$115.44k - $186.16k
...Anticipates emerging business trends and regulatory/risk issues as a basis for recommending... ...management where required Leads the submission and discussion on the Quarterly Business... ...standardized situations - Continuous Reading, writing and comprehending instructions -...RegulatoryWork at officeLocal areaWork from homeFlexible hours- ...labor issues for private-sector clients, providing advice on regulatory compliance, and representing clients before regulatory agencies... ...have at least 5 years of experience, excellent legal research, writing, and oral advocacy skills, and be proactive. The firm offers...Regulatory
- ...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
- ...Assessment framework to ensure the applicable regulatory compliance risks and internal controls... ...and provides approval for document submissions to these entities, based on... ...standardized situations - Continuous Reading, writing and comprehending instructions - Continuous...RegulatoryFull timeWork experience placementWork at officeImmediate startWork from homeFlexible hours
- ...and treatment delivery models, ensuring care meets clinical and regulatory standards. Follow infection control and environmental safety... ...protocols within the facility. Demonstrate proficiency in reading, writing, speaking, and understanding English for effective...RegulatoryFull timeContract workReliefFlexible hours
- ...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
- ...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... ...desirable Excellent Excel skills required Professional writing abilities required KNOWLEDGE, SKILLS, ABILITIES Solid...RegulatoryWork experience placementWork at officeRemote workWork from home
- ...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 - $117.52k
...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- ...actual matters for real clients. In addition to research and writing opportunities, as part of their work assignments, summer associates... ...the opportunity to attend client meetings, court appearances, regulatory hearings, transactional closings, and legislative proceedings....RegulatoryWork experience placementSummer workWork at office
$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$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- ...more areas of expertiseAnticipates emerging business trends and regulatory/risk issues as a basis for recommending large-scale product,... ...problems involving standardized situations – ContinuousReading, writing and comprehending instructions – ContinuousAdding, subtracting...RegulatoryWork at officeLocal areaWork from homeFlexible hours
$100k - $130k
...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$72.28k - $108.16k
...using PowerApps/PowerAutomate (2+ years) Proficient in Excel writing VBA and using complex formulas/functions (4+ years)... ...AML/ATF/Sanctions/ABAC matters affecting the business based on regulatory compliance requirements and industry best practice, including,...RegulatoryWork experience placementWork at officeLocal areaWork from homeFlexible hours- ...practices (GMP) and work in a manner consistent with all company regulatory, food safety, quality, and sanitation requirements The... ...to communicate clearly and effectively, both verbally and in writing Able to work in collaboration effectively and foster good teamwork...RegulatoryContract workWork at officeMonday to FridayShift workAfternoon shift
- ...with organizational policies, payer requirements and applicable regulatory guidelines. SUPERVISORY RESPONSIBILITIES Coordinates and... ...dexterity, and the ability to communicate both verbally and in writing. Is required to travel to and from office locations as needed....RegulatoryWork at officeRemote work
- ...appear on behalf of private clients before municipal and state regulatory boards and administrative agencies on licensing and permitting... ...legal and educational credentials, superior research and writing skills, and a strong commitment to providing clients with excellent...RegulatoryRemote work
- ...Utilities We are pleased to offer an exciting opportunity for a Regulatory and Rates Analyst to work in a hybrid capacity from one of our... ...desirable Excellent Excel skills required Professional writing abilities required Knowledge, Skills, Abilities Solid background...RegulatoryWork experience placementWork at officeRemote workWork from home
$116k - $174k
...innovation and creating the best experience for job seekers. (*Comscore, Total Visits, March 2025) Day to Day As a Business Strategist III - Strategic Partnerships, you will be a high-impact individual contributor responsible for the strategy and execution of...Work experience placementLocal areaRemote workShift work- ...Transformation Manager supports the overall coordination of US regulatory remediation including oversight over all workstreams and... ...problems involving standardized situations - Continuous Reading, writing and comprehending instructions - Continuous Adding, subtracting...RegulatoryFull timeTemporary workWork experience placementLocal areaWork from homeFlexible hours
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