Regulatory Specialist
Spectraforce
South Portland, Maine
2 hours ago
Job Description
Position Title:Regulatory Specialist
Location: South Portland ME
Assignment Duration: 8 months
The role 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 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
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 35.00/daily.
Location: South Portland ME
Assignment Duration: 8 months
The role 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 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
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 35.00/daily.