Regulatory Affairs Specialist II

Title: Regulatory Affairs Specialist

Location: Scarborough, ME

Shift: Mon - Fri 8am to 5pm

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 Client 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