Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the EU Regulatory Strategist: IVDR Writing & Submissions in South Portland, ME vacancy
  •  ...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

    Planet Pharma

    South Portland, ME
    8 hours ago
  • 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

    ProKatchers LLC

    South Portland, ME
    3 days ago
  •  ...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... 
    Regulatory
    Work at office

    GForce Life Sciences

    South Portland, ME
    2 days ago
  •  ...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

    ProKatchers

    South Portland, ME
    3 days ago
  • 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

    South Portland, ME
    1 day ago
  • 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

    Experis

    South Portland, ME
    1 day ago
  • 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.... 
    Regulatory
    Full time

    BioTalent

    Portland, ME
    1 day ago
  •  ...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

    BCG Attorney Search

    Portland, ME
    2 days ago
  •  ...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... 
    Regulatory
    Work at office
    Local area

    Dairy Farmers of America

    Portland, ME
    4 days ago
  • $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,... 
    Regulatory
    Work at office

    Preti Flaherty

    Portland, ME
    4 days ago
  •  ...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... 
    Regulatory
    Contract work
    Relief

    Reliant Rehabilitation

    Portland, ME
    1 day ago
  • $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... 
    Regulatory
    Hourly pay
    Full time
    Contract work
    For contractors
    For subcontractor
    Work at office
    Local area
    Remote work
    Flexible hours

    Woodard & Curran

    Portland, ME
    1 day ago
  • $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... 
    Regulatory
    Full time
    Flexible hours
    Shift work

    WEX

    Portland, ME
    14 hours ago
  •  ...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,... 
    Regulatory
    Work experience placement
    Work at office

    TD Bank

    Portland, ME
    1 day ago
  • $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 &... 
    Regulatory
    Full time
    Work experience placement
    Remote work
    Flexible hours
    Shift work

    Milliman

    Portland, ME
    3 days ago
  •  ...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... 
    Regulatory
    Local area
    Remote work

    Team Select Home Care

    Portland, ME
    2 days ago
  • $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... 
    Regulatory
    Full time
    Part time
    Work at office
    Immediate start
    Flexible hours
    Shift work

    Maine Medical Center

    Portland, ME
    1 day ago
  •  ...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... 
    Regulatory
    Full time
    Work at office
    Shift work
    Night shift

    Portland General Electric

    Portland, ME
    2 days ago
  •  ...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... 
    Regulatory
    Weekly pay
    Temporary work
    Flexible hours

    Experis

    South Portland, ME
    4 days ago
  • ## 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... 
    Regulatory
    Work at office
    Local area
    Work from home
    Flexible hours

    TD Bank

    Portland, ME
    3 days ago
  • $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 pay
    Full time

    Fisher & Phillips

    Portland, ME
    1 day ago
  • $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... 
    Regulatory
    Full time
    Work at office

    ACS Professional Staffing

    Falmouth, ME
    1 day ago
  •  ...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... 
    Regulatory
    Temporary work
    Flexible hours
    Shift work

    Abbott

    South Portland, ME
    3 days ago
  •  ...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... 
    Regulatory
    Remote job
    Work from home
    Flexible hours

    Pharmacy Careers

    Portland, ME
    4 days ago
  •  ...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... 
    Regulatory
    Remote job
    Work from home

    Pharmacy Careers

    Portland, ME
    2 days ago
  • $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... 
    Regulatory
    Local area

    Newmark ltd

    Portland, ME
    2 days ago
  •  ...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... 
    Regulatory
    Temporary work
    Worldwide
    Flexible hours
    Shift work

    Abbott

    South Portland, ME
    3 days ago
  •  ...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,... 
    Regulatory
    Local area

    HDR

    Portland, ME
    1 day ago
  • $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... 
    Regulatory
    Temporary work
    For contractors
    Work at office
    Local area
    Remote work
    Relocation
    Home office
    Relocation package

    ApplyMint

    Portland, ME
    1 day ago
  •  ...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... 
    Regulatory
    Full time
    Local area
    Monday to Friday

    Oakhurst Dairy

    Portland, ME
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to EU Regulatory Strategist: IVDR Writing & Submissions. Be the first to apply!