Senior Regulatory Specialist

Job Description 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 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.
• 4+ years’ experience in Regulatory Affairs role.
• Strong knowledge of IVDR and EU regulatory requirements is required.

• 1+ years’ experience in an IVD or medical device manufacturing environment.

• 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.