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
- 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...Regulatory
- 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...Regulatory
- 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
- ...Duties Represent clients in state and federal courts and before regulatory agencies. Handle cases involving wrongful discharge,... ...of experience in labor and employment law. Strong research and writing abilities. Superior verbal and interpersonal communication skills...Regulatory
- ...ensure effective quality execution, continuous improvement, and regulatory compliance. In conjunction with plant operations, maintain an... ...to communicate clearly and effectively, both verbally and in writing, for a diverse range of internal and external audiences· Able...RegulatoryWork at officeLocal area
$105k - $109k
...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,...RegulatoryWork at office- ...and treatment delivery models to ensure care meets clinical and regulatory standardsDeliver care that aligns with treatment goals and... ...protocols within the facilityDemonstrate proficiency in reading, writing, speaking, and understanding English for effective...RegulatoryContract workRelief
$100k - $165k
...Documents. Interfacing with state and local regulatory agencies and permitting officials... ...trends, equipment, and processes. Superior writing, communication, and presentation skills... ...by replying “STOP.”Unsolicited agency submissions without a signed agreement are not...RegulatoryHourly payFull timeContract workFor contractorsFor subcontractorWork at officeLocal areaRemote workFlexible hours$110.4k - $132.8k
...Travel, and Benefits LOBs to ensure initiatives align with unique regulatory, financial integrity, and operational needs.PROGRAM EXECUTION... ...partners rather than direct reporting lines. Excellent writing and verbal communication skills, with the ability to facilitate...RegulatoryFull timeFlexible hoursShift work- ...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
$104.9k - $199.07k
...funding and healthcare financing, enterprise risk management and regulatory compliance, data analytics and business transformation as well... ...Communication: A clear, confident, persuasive communicator in writing and in person, including at the executive level.Organized &...RegulatoryFull timeWork experience placementRemote workFlexible hoursShift work- ...processes and materials as assigned by the RVPCO; inclusive of regulatory and payer changes Performs/ensures performance and process... ...Ensures that the following information/instruction is given in writing to the patient/caregiver/ representative as applicable Available...RegulatoryLocal areaRemote work
$61.26k - $82.87k
...projects • Assist in the development and writing of study protocols and other study... ...study manuals, etc. • Facilitation of submissions to the MaineHealth Institutional Review... ...including data entry, data management, regulatory oversight, and project management to assist...RegulatoryFull timePart timeWork at officeImmediate startFlexible hoursShift work- ...reliability, customer affordability and regulatory requirements. Working across... ...other technical support for regulatory submissions, testimony, data requests and stakeholder... ...from another’s perspective. Skills in writing technical and business requirements. P...RegulatoryFull timeWork at officeShift workNight shift
- ...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 and reports...RegulatoryWeekly payTemporary workFlexible hours
- ## Senior Specialized Finance Manager (US) - Regulatory Policy and ReviewApplyremote type: On Sitelocations: Portland, Maine: Greenville... ...involving standardized situations - Continuous* Reading, writing and comprehending instructions - Continuous* Adding, subtracting...RegulatoryWork at officeLocal areaWork from homeFlexible hours
$29.44 - $46.15 per hour
...client or accounting. Participating in the timely review and submission of pre-bills and/or client bills. Requirements Minimum of a high... .... Accurate typing at a net speed of 65+ wpm (shorthand/speed writing a plus). Strong computer proficiency in the use of MS Office (...Hourly payFull time$60k - $85k
ACS Professional Staffing is seeking a Staff Regulatory Consultant in Falmouth, Maine. This hybrid full-time position supports hydroelectric... ...years of experience in environmental regulatory work, strong writing skills, and proficiency with Microsoft Office. The position...RegulatoryFull timeWork at office- ...Title: Regulatory Affairs Associate Location: South Portland, ME Duration: 12 Months Shifts: 8AM TO 4:30PM 100% Onsite... ...specialized knowledge in directing development of product registration submission, progress reports, supplements, amendments, or periodic...RegulatoryTemporary workFlexible hoursShift work
- ...Document recommendations and decisions according to health-plan and regulatory requirements. Participate in quality initiatives and peer-... ...are highly encouraged to apply. Skills: Excellent clinical writing, critical thinking, and communication. Why This Role? ~100...RegulatoryRemote jobWork from homeFlexible hours
- ...Pharmacist Fair Medication Access Work From Home | Strong Clinical Writing Focus Combine clinical expertise with advocacy in a fully... .... Apply plan policies, evidence-based guidelines, and regulatory requirements to reach determinations. Prepare clear written...RegulatoryRemote jobWork from home
$50k
...counsel. The appraiser also manages assignments, ensures QA/QC and regulatory compliance, mentors junior staff, and supports proposals and... ...Real Estate Appraiser. Must have experience and be skilled in writing appraisal and appraisal reviews of complex commercial...RegulatoryLocal area- ...Title: Regulatory Specialist I Location: South Portland, ME Duration: 12 Months... ...and teams. Prepares U.S. regulatory submissions and/or registration documents for international... ...and regulatory information in order to write submission documents. Maintains...RegulatoryTemporary workWorldwideFlexible hoursShift work
- ...CEPA) is a plus· Research and interpret scientific literature, regulatory programs, guidance, and applications· Collect project-related... ...discipline Proficient with MS Office Self-starter with excellent writing and communication skills Strong conceptual, organizational,...RegulatoryLocal area
$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... ...resolve entry discrepancies and support corrective actions. Monitor submission status and assist with resolving ACE filing errors, CBP...RegulatoryTemporary workFor contractorsWork at officeLocal areaRemote workRelocationHome officeRelocation package- ...practices (GMP) and work in a manner consistent with all corporate regulatory, food safety, quality, and sanitation requirements · The... ...to communicate clearly and effectively, both verbally and in writing · Able to add, subtract, multiply and divide in all units of...RegulatoryFull timeLocal areaMonday to Friday
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