Regulatory Affairs Specialist
2 weeks ago
Role: Regulatory Specialist II
Location: Lake Forest, IL, Santa Clara, CA, Boston, MA
Duration: 6-12 Months
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
- 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.
-
Regulatory Affair Specialist
20 hours ago
Lake Forest, United States Collabera Full timeDescription Home Search Jobs Job Description Regulatory Affair Specialist Contract: Lake Forest, Illinois, US Salary: $35.00 Per Hour Job Code: 348942 End Date: 2024-06-01 Days Left: 4 days, 3 hours left Apply Job Description: RESPONSIBILITIES: Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation...
-
Regulatory Affairs Specialist
5 days ago
Lake Forest, United States GForce Life Sciences Full timeThe position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations. TERM & START 1-year contract starting 6/10/24 with possibility to extend On-site in Lake Forest, IL (60045) Pay Rate: $30-35/hr depending on...
-
Regulatory Affairs Specialist
4 days ago
Lake Forest, United States GForce Life Sciences Full timeThe position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations.TERM & START 1-year contract starting 6/10/24 with possibility to extendOn-site in Lake Forest, IL (60045)Pay Rate: $30-35/hr depending on...
-
Regulatory Affairs Specialist
4 days ago
Lake Forest, United States GForce Life Sciences Full timeThe position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations.TERM & START 1-year contract starting 6/10/24 with possibility to extendOn-site in Lake Forest, IL (60045)Pay Rate: $30-35/hr depending on...
-
Regulatory Affairs Specialist
4 days ago
Lake Forest, United States GForce Life Sciences Full timeThe position of Regulatory Affairs Specialist II is within our client's Infectious Disease business unit. In this role, you will prepare documentation for EU Technical Files and international product registrations.TERM & START 1-year contract starting 6/10/24 with possibility to extendOn-site in Lake Forest, IL (60045)Pay Rate: $30-35/hr depending on...
-
Regulatory Affairs Specialist
2 weeks ago
Lake Forest, United States INTELLECTT INC Full timeRole: Regulatory Specialist II Location: Lake Forest, IL, Santa Clara, CA, Boston, MA Duration: 6-12 Months 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 Affairs Specialist
3 weeks ago
Lake Forest, United States Intellectt Inc Full timeRole: Regulatory Specialist IILocation: Lake Forest, IL, Santa Clara, CA, Boston, MADuration: 6-12 Months 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
2 weeks ago
Lake Forest, United States Intellectt Inc Full timeRole: Regulatory Specialist IILocation: Lake Forest, IL, Santa Clara, CA, Boston, MADuration: 6-12 Months 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
7 days ago
Lake Forest, United States INTELLECTT INC Full timeRole: Regulatory Specialist II Location: Lake Forest, IL, Santa Clara, CA, Boston, MA Duration: 6-12 Months 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 Affairs Associate
1 month ago
Lake Forest, United States GForce Life Sciences Full timeRegulatory Affairs Associate JR – Lake Forest, IL MUST BE ABLE TO WORK ON A W2Job Title: Regulatory Affairs Associate JRJob Summary: The Regulatory Affairs Associate Jr. supports the execution of External Regulations Standards and Guidance Documents packages by tracking and monitoring ePAS packages from draft to final closure. This role prepares metrics...
-
Regulatory Affairs Associate
1 month ago
Lake Forest, United States GForce Life Sciences Full timeRegulatory Affairs Associate JR – Lake Forest, IL MUST BE ABLE TO WORK ON A W2Job Title: Regulatory Affairs Associate JRJob Summary: The Regulatory Affairs Associate Jr. supports the execution of External Regulations Standards and Guidance Documents packages by tracking and monitoring ePAS packages from draft to final closure. This role prepares metrics...
-
Regulatory Affairs Associate
1 month ago
Lake Forest, United States GForce Life Sciences Full timeRegulatory Affairs Associate JR – Lake Forest, IL MUST BE ABLE TO WORK ON A W2Job Title: Regulatory Affairs Associate JRJob Summary: The Regulatory Affairs Associate Jr. supports the execution of External Regulations Standards and Guidance Documents packages by tracking and monitoring ePAS packages from draft to final closure. This role prepares metrics...
-
Regulatory Affairs Associate
3 weeks ago
Lake Forest, United States PSG Global Solutions Full timeDescription We're looking for a Regulatory Affairs Associate, working in Biotechnology/Medical Devices industry in 100 Abbott Park Road, Lake Forest, Illinois, 60064, United States. Job description: Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring...
-
Regulatory Compliance Specialist I
3 weeks ago
Lake Forest, United States Beacon Hill Full timeThe Regulatory Specialist will support the Regulatory Department with implementing and maintaining processes and procedures intended to ensure Company’s products are compliant with all applicable laws and regulations, and internal policies. This role will involve tracking and analyzing federal, state and local legislation, assessing the implications of...
-
Regulatory Compliance Specialist I
2 weeks ago
Lake Forest, United States Beacon Hill Full timeThe Regulatory Specialist will support the Regulatory Department with implementing and maintaining processes and procedures intended to ensure Company’s products are compliant with all applicable laws and regulations, and internal policies. This role will involve tracking and analyzing federal, state and local legislation, assessing the implications of...
-
Regulatory Compliance Specialist I
3 weeks ago
Lake Forest, United States Beacon Hill Full timeThe Regulatory Specialist will support the Regulatory Department with implementing and maintaining processes and procedures intended to ensure Company’s products are compliant with all applicable laws and regulations, and internal policies. This role will involve tracking and analyzing federal, state and local legislation, assessing the implications of...
-
Regulatory Specialist II
4 weeks ago
Lake Forest, United States Collabera Full timeJob DescriptionJob 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...
-
Regulatory Affairs Associate Jr
2 weeks ago
Lake Forest, United States Collabera Full timeDescription Home Search Jobs Job Description Regulatory Affairs Associate Jr Contract: Lake Forest, Illinois, US Salary: $27.00 Per Hour Job Code: 348484 End Date: 2024-05-18 Days Left: 3 hours left Apply Job Description: •Supports execution of External Regulations Standards and Guidance Documents packages through tracking and monitoring ePAS...
-
Regulatory Affairs Associate Jr
1 week ago
Lake Forest, United States Collabera Full timeDescription Home Search Jobs Job Description Regulatory Affairs Associate Jr Contract: Lake Forest, Illinois, US Salary: $27.00 Per Hour Job Code: 348484 End Date: 2024-05-18 Days Left: 20 hours left Apply Job Description: •Supports execution of External Regulations Standards and Guidance Documents packages through tracking and monitoring ePAS...
-
Regulatory Specialist II
2 weeks ago
Lake Forest, United States Spectraforce Technologies Full timePosition Title: Regulatory Specialist II Location: Lake Forest, IL,60045 Duration: 12 months. Shift Time: 8am - 5:00pm Job 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...