Regulatory Specialist

2 weeks ago


Scarborough, United States Viva USA, Inc. Full time

Title: Regulatory Specialist - Onsite

Description:


Regulatory Specialist II

Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function

Skills: Knowledge of regulations and standards affecting IVDs and/or biologics

Education:

BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.

Duties:

Responsible for implementing and maintaining the effectiveness of the quality system.

Supports manufacturing/operations day to day activities for change control. Provides consultation/advice to regulatory specialist for change control and product development.

Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams.

Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.

Handles regulatory activities involved in documentation,labeling,field support. Applies regulatory and technical knowledge to a wide variety of complex work assignments.

Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.

Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

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 the 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

Note :

On Site

8am - 5pm - Monday - Friday


  • 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...


  • 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,...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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...


  • 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: ·...

  • 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

    6 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...