- 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 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.
- Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.
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Regulatory Specialist II
1 week ago
The Fountain Group Scarborough, United StatesHello, · 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 yea ...
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Regulatory Specialist II
1 week ago
Collabera Scarborough, United StatesHome · Search Jobs · Job Description · Regulatory Specialist II · Contract: Scarborough, Maine, US · Salary: $50.00 Per Hour · Job Code: · End Date: · Days Left: 9 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Rasto ...
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Regulatory Specialist II
1 day ago
Collabera Scarborough, United StatesHome · Search Jobs · Job Description · Regulatory Specialist II · Contract: Scarborough, Maine, US · Salary: $50.00 Per Hour · Job Code: · End Date: · Days Left: 1 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Rasto ...
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Regulatory Affairs Specialist
3 weeks ago
GForce Life Sciences Scarborough, United StatesRegulatory Affairs Specialist II – On-site in Scarborough, ME · 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 commer ...
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Regulatory Specialist
4 weeks ago
INTELLECTT INC Scarborough, United StatesRole : Regulatory Specialist IILocation : Scarborough, ME Duration : 06+ Months on W2 (Contract only)Shift Timings : 8 am - 5 pmSkills Looking For:- The project entails a regulatory affairs specialist position focusing on IVDR compliance for European regulations.- Strong IVDR (In ...
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Regulatory Specialist
4 weeks ago
ProKatchers Scarborough, United StatesJob 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 f ...
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Regulatory Specialist
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Rhode Island Energy Cumberland, United States Regular, Full timeResponsibilities · Serve as the PUC liaison and ensure systemwide consistency in the application of Chapter 10 and other RI regulations. · Develop process improvements to support the goals and objectives of the CCC, coach, counsel, and train employees as appropriate. · Identify o ...
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Regulatory Affairs Specialist II
3 weeks ago
Axelon Scarborough, United StatesTitle: 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 ...
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Regulatory Affairs Specialist II
2 weeks ago
Collabera Scarborough, United StatesJob 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 perio ...
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Regulatory Affairs Specialist II
3 weeks ago
Collabera Scarborough, United StatesJob 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 b ...
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Regulatory Affairs Specialist II
3 weeks ago
Collabera Scarborough, United StatesJob 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 review ...
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Regulatory Affairs Specialist II
3 weeks ago
Axelon Scarborough, United StatesTitle: Regulatory Affairs SpecialistLocation: Scarborough, MEShift: Mon - Fri | 8am to 5pmRESPONSIBILITIES: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR).Provides regulatory support for diagnostic product develo ...
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Regulatory Specialist II
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DivIHN Integration Inc Scarborough, United StatesDivIHN (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 200 ...
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Regulatory Affairs Specialist
3 weeks ago
GForce Life Sciences Scarborough, United StatesRegulatory Affairs Specialist II – On-site in Scarborough, ME · RESPONSIBILITIES · Implement & maintain the effectiveness of the quality system · Support manufacturing/operations day to day activities for change control · Assist regulatory specialist in change control- and produ ...
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Regulatory Specialist II
3 weeks ago
The Fountain Group Scarborough, United StatesHello,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-$56Experience:2-5 years regulatory experience and/or 2 ...
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Regulatory Specialist II
1 week ago
Collabera Scarborough, United StatesHome · Search Jobs · Job Description · Regulatory Specialist II · Contract: Scarborough, Maine, US · Salary: $50.00 Per Hour · Job Code: · End Date: · Days Left: 12 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Rast ...
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Regulatory Specialist II
4 weeks ago
The Fountain Group Scarborough, United StatesHello, · 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 exp ...
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Regulatory Specialist II
5 days ago
Collabera Scarborough, United StatesHome · Search Jobs · Job Description · Regulatory Specialist II · Contract: Scarborough, Maine, US · Salary: $50.00 Per Hour · Job Code: · End Date: · Days Left: 5 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Rasto ...
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Regulatory Specialist II
6 days ago
Collabera Scarborough, United StatesHome · Search Jobs · Job Description · Regulatory Specialist II · Contract: Scarborough, Maine, US · Salary: $50.00 Per Hour · Job Code: · End Date: · Days Left: 6 days, 3 hours left · Apply · To discuss more about this job opportunity, please reach out to Chitrank Rasto ...
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Regulatory Affairs Specialist
4 weeks ago
GForce Life Sciences Scarborough, United StatesRegulatory Affairs Specialist II On-site in Scarborough, ME · RESPONSIBILITIES · Implement & maintain the effectiveness of the quality system · Support manufacturing/operations day to day activities for change control · Assist regulatory specialist in change control- and pro ...
Regulatory Specialist - Scarborough, United States - ProKatchers LLC
Description
Job Title: Regulatory Specialist
Location: 04074, Scarborough, Maine, United States
Duration: 06 Month
Job Description:
Basic Qualifications | Education: