Regulatory Affairs Specialist

ProKatchers LLC; South Portland (ME); On-site; USD 65,000 - 85,000; Full time

Job summary

ProKatchers LLC is seeking a Regulatory Affairs Specialist II in South Portland, ME. This role involves technical writing in compliance with In Vitro Diagnostic medical device Regulation (IVDR) and providing regulatory support for diagnostic product development. The position requires a strong understanding of regulatory strategies to achieve product clearance in the EU and globally. Candidates must hold at least a High School diploma with experience in regulatory affairs being a plus.

Qualifications

• High School diploma required.
• Experience in regulatory affairs, particularly in the medical device industry is preferred.

Responsibilities

• Responsible for technical writing of files in accordance with IVDR.
• Provides regulatory support for diagnostic product development.
• Develops regulatory strategies for product clearance in the EU.

Job description

Job Title : Regulatory Affairs Specialist II

Location : South Portland, ME 04106

Duration : 08 Months

Education : High School

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 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.