Regulatory Affairs Specialist

2 weeks ago

Scarborough, United States TalentBurst Full time

Title: Regulatory Affairs Specialist II

Location Scarborough Maine

Duration 6 months

The position of Regulatory Affairs Specialist II is within our Infectious Disease business

unit. In this role you will prepare documentation for EU Technical Files and international

product registrations.

This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

? Responsible for technical writing of files in accordance with In Vitro Diagnostic medical

device Regulation (IVDR).

? Provides regulatory support for diagnostic product development and commercial

diagnostic products.

? Develops regulatory strategies for products in development and for modified products to

achieve clearance/approval in the EU and internationally.

? Provides regulatory support to regional regulatory teams to assist with submissions,

license renewals, and license amendments.

? Researches and communicates scientific and regulatory information in order to write

submission documents.

? Compiles and publishes all material required for submissions, license renewals, and

annual registrations.

? Maintains approvals/licenses/authorizations for existing marketing authorizations.

? Assesses product, manufacturing, and labeling changes for regulatory reporting impact

and compliance to regulations.

? Develops internal procedures and tools.

? Conducts informational or training sessions for stakeholders.

? Organizes and maintains hard copy and electronic department files.

? Demonstrates commitment to the development, implementation and effectiveness of

Client Quality Management System per ISO, FDA, and other regulatory agencies.

? Responsible for exhibiting professional behavior with both internal/external business

associates that reflects positively on the company and is consistent with the company's

policies and practices.

BASIC QUALIFICATIONS | EDUCATION:

? Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other related

technical field or the equivalent combination of education and experience.

? 4+ years' experience in Regulatory Affairs role.

? Strong knowledge of IVDR and EU regulatory requirements is required.

PREFERRED QUALIFICATIONS:

? 1+ years' experience in an IVD or medical device manufacturing environment.

COMPETENCIES:

? Good knowledge of EU and international regulations.

? Demonstrated written and verbal communication skills.

? Strong time management skills, with the ability to work on multiple projects

simultaneously.

? Ability to work independently as well as within a team.

? Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio

  • Regulatory Affairs Specialist II

    4 days ago

    Scarborough, United States DivIHN Integration Full time

    DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to...

  • Regulatory Affairs Specialist II

    2 days ago

    Scarborough, United States Axelon Full time

    Title: Regulatory Affairs Specialist Location: Scarborough, ME Shift: Mon - Fri | 8am to 5pm RESPONSIBILITIES: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops regulatory...

  • Regulatory Affairs Specialist II

    3 days ago

    Scarborough, United States Collabera Full time

    Job Description Job Description · The position of Regulatory Affairs Specialist II is within our Infectious Disease business unit. In this role you will prepare documentation for EU Technical Files and international product registrations. · This job description will be reviewed periodically and is subject to change by management. Responsibilities: ·...

  • Regulatory Specialist II

    2 weeks ago

    Scarborough, United States The Fountain Group Full time

    Hello, This is ShivaRaj from The Fountain Group, we are currently seeking a Regulatory Specialist II for a prominent client of ours. This position is located in Scarborough, ME. Details for the position are as follows: Pay: $47-$56 Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality,...

  • Regulatory Specialist II

    1 week ago

    Scarborough, United States Spectraforce Technologies Full time

    Job Title: Regulatory Specialist IILocation: Scarborough, ME 04074Duration: 7 MonthsDuties:Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).Provides regulatory support for diagnostic product development and commercial diagnostic products.Develops regulatory strategies for products in...

  • Regulatory Specialist II

    2 weeks ago

    Scarborough, United States Spectraforce Technologies Full time

    Job Title: Regulatory Specialist II Location: Scarborough, ME 04074 Duration: 7 Months Duties: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops regulatory strategies for products in...

  • Regulatory Specialist II

    1 week ago

    Scarborough, United States DivIHN Integration Full time

    DivIHN (pronounced "divine") is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to...

  • Regulatory Specialist

    2 weeks ago

    Scarborough, United States ProKatchers LLC Full time

    Job Title: Regulatory SpecialistLocation: 04074, Scarborough, Maine, United StatesDuration: 06 MonthJob Description:Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).Provides regulatory support for diagnostic product development and commercial diagnostic products.Develops regulatory strategies...

  • Regulatory Specialist

    2 weeks ago

    Scarborough, United States ProKatchers Full time

    Job Title: Regulatory Specialist Location: 04074, Scarborough, Maine, United States Duration: 06 Month Job Description: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops regulatory...

  • Regulatory Specialist

    3 weeks ago

    Scarborough, United States ProKatchers LLC Full time

    Job Title: Regulatory SpecialistLocation: 04074, Scarborough, Maine, United StatesDuration: 06 MonthJob Description:Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).Provides regulatory support for diagnostic product development and commercial diagnostic products.Develops regulatory strategies...

  • Regulatory Specialist

    3 weeks ago

    Scarborough, United States ProKatchers LLC Full time

    Job Title: Regulatory SpecialistLocation: 04074, Scarborough, Maine, United StatesDuration: 06 MonthJob Description:Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).Provides regulatory support for diagnostic product development and commercial diagnostic products.Develops regulatory strategies...

  • A/R Specialist

    3 weeks ago

    Scarborough, United States New England Life Care Full time

    Job DescriptionJob DescriptionNew England Life Care (NELC) is one of the fastest growing home infusion therapy services companies in New England and is the region’s only non-profit home infusion provider. NELC is a hospital collaborative serving more than 70 hospital systems in Maine, New Hampshire and Massachusetts. NELC was created by local hospitals to...

  • Quality Specialist

    5 days ago

    Scarborough, United States Abbott Laboratories Full time

    About AbbottAbbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.The Quality Specialist – Post Market Surveillance...

  • Tumor Registrar

    2 weeks ago

    Scarborough, United States Maine Health Full time

    Full Time 100 Campus Drive Professional - Nonclinical Day Shift MaineHealth is actively recruiting for a Tumor Registrar. This is a 100% remote role. Position Summary The Tumor Registrar position is responsible for the identification, collection, and management of health, medical and outcome information on all oncology patients and in accordance with...

  • Tumor Registrar

    2 weeks ago

    Scarborough, United States Maine Medical Center Full time

    Summary MaineHealth is actively recruiting for a Tumor Registrar. This is a 100% remote role. Position Summary The Tumor Registrar position is responsible for the identification, collection, and management of health, medical and outcome information on all oncology patients and in accordance with established policies, procedures and regulatory requirements....

  • Tumor Registrar

    1 week ago

    Scarborough, United States MaineHealth Full time

    Summary MaineHealth is actively recruiting for a Tumor Registrar. This is a 100% remote role. Position Summary The Tumor Registrar position is responsible for the identification, collection, and management of health, medical and outcome information on all oncology patients and in accordance with established policies, procedures and regulatory requirements....

  • Project Management

    2 days ago

    Scarborough, United States New England Cancer Specialists Full time

    Job DescriptionJob DescriptionNew England Cancer Specialists (NECS) is looking for a Full time 5 day a week Project Manager in our Scarborough Clinic. The Project Manager will provide support in the planning, implementation and tracking of assigned projects to ensure successful development, completion and implementation. They will be responsible for creating...