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Job Requirements of Regulatory Specialist II:
-
Employment Type:
Full-Time
-
Location:
South Portland, ME (Onsite)
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Regulatory Specialist II
Generis Tek Inc.
South Portland, ME (Onsite)
Full-Time
Please Contact : To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Jigar Kachhia at email address can be reached on #
We have Contract role Regulatory Specialist for our client at South Portland ME. Please let me know if you or any of your friends would be interested in this position.
Position Details: Regulatory Specialist - South Portland ME
Location : South Portland ME 04074
Project Duration : 12+ Months Contract
Job Description:
The position of Regulatory Affairs Specialist II is within Abbott's Infectious Disease business unit. In this role you will prepare documentation for EU Technical Files and international product registrations.
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 Abbott 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 MS Office, including Word, Excel, PowerPoint and Visio
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Jigar Kachhia at email address can be reached on #
About generis tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.
630-576-1904
.We have Contract role Regulatory Specialist for our client at South Portland ME. Please let me know if you or any of your friends would be interested in this position.
Position Details: Regulatory Specialist - South Portland ME
Location : South Portland ME 04074
Project Duration : 12+ Months Contract
Job Description:
The position of Regulatory Affairs Specialist II is within Abbott's Infectious Disease business unit. In this role you will prepare documentation for EU Technical Files and international product registrations.
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 Abbott 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 MS Office, including Word, Excel, PowerPoint and Visio
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Jigar Kachhia at email address can be reached on #
630-576-1904
.About generis tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.
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