Regulatory Affairs Specialist
3 weeks ago
Title: Regulatory Affairs Specialist IILocation Scarborough MaineDuration 6 monthsThe position of Regulatory Affairs Specialist II is within our Infectious Disease businessunit. In this role you will prepare documentation for EU Technical Files and internationalproduct 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 medicaldevice Regulation (IVDR).Provides regulatory support for diagnostic product development and commercialdiagnostic products.Develops regulatory strategies for products in development and for modified products toachieve 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 writesubmission documents.Compiles and publishes all material required for submissions, license renewals, andannual registrations.Maintains approvals/licenses/authorizations for existing marketing authorizations.Assesses product, manufacturing, and labeling changes for regulatory reporting impactand 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 ofClient Quality Management System per ISO, FDA, and other regulatory agencies.Responsible for exhibiting professional behavior with both internal/external businessassociates that reflects positively on the company and is consistent with the company'spolicies and practices.BASIC QUALIFICATIONS | EDUCATION:Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other relatedtechnical 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 projectssimultaneously.Ability to work independently as well as within a team.Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio#J-18808-Ljbffr
by Jobble
-
Regulatory Affairs Specialist II
4 days ago
Scarborough, United States Axelon Full timeTitle: 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
2 weeks ago
Scarborough, United States Axelon Full timeTitle: 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
2 weeks ago
Scarborough, United States Collabera Full timeJob 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 days ago
Scarborough, United States The Fountain Group Full timeHello, 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
3 weeks ago
Scarborough, United States The Fountain Group Full timeHello, 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
4 weeks ago
Scarborough, United States ProKatchers LLC Full timeJob 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 timeJob 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
4 weeks ago
Scarborough, United States ProKatchers LLC Full timeJob 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
4 weeks ago
Scarborough, United States ProKatchers Full timeJob 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...
-
A/R Specialist
2 days ago
Scarborough, United States New England Life Care Full timeJob 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...
-
A/R Specialist
1 month ago
Scarborough, United States New England Life Care Full timeJob 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...
-
Tumor Registrar
4 weeks ago
Scarborough, United States Maine Health Full timeFull 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
4 weeks ago
Scarborough, United States Maine Medical Center Full timeSummary 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....
-
Employment Labor
4 days ago
Scarborough, United States Retail Business Services Full timeAddress: USA-ME-Scarborough-145 Pleasant Hill Rd Store Code: Legal (2760981) Ahold Delhaize USA, a division of global food retailer Ahold Delhaize, is part of the U.S. family of brands, which also includes five leading omnichannel grocery brands – Food Lion, Giant Food, The GIANT Company, Hannaford and Stop & Shop. Ahold Delhaize USA associates...
-
Specialist Process Assurance
22 hours ago
Scarborough, United States ADUSA Distribution Full timeADUSA Distribution is the distribution company of Ahold Delhaize USA, providing distribution services to one of the largest grocery retail supply chains in the nation. ADUSA Distribution fosters a culture that inspires and empowers our associates to always deliver exceptional service and value. Our team is supporting the supply chain network evolution to an...
-
Project Management
2 weeks ago
Scarborough, United States New England Cancer Specialists Full timeJob 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...
-
Project Management
7 days ago
Scarborough, United States New England Cancer Specialists Full timeJob Description New 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 project...
