Regulatory Affairs Associate - Lake Forest, United States - DivIHN Integration

Description

Description:

In this role you will prepare documentation for EU Technical Files and international product registrations.

This job description will be reviewed periodically and is subject to change by management.

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.

Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).

Review/approval of engineering study protocols/reports and validation study protocols/reports.

Review and approval of manufacturing changes for Class III implantable medical devices.

May require an advanced degree and 5-8 years of direct experience in the field.

Recent experience with Class III implantable medical devices;

Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations.

Relies on extensive experience and judgment to plan and accomplish goals.

Performs a variety of tasks.

May lead and direct the work of others.

A wide degree of creativity and latitude is expected.

Typically reports to a manager or head of a unit/department.

Duties:

Candidate will be 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.

Maintains approvals/licenses/authorizations for existing marketing authorizations.

Experience:

4+ years' experience in Regulatory Affairs role; Strong knowledge of IVDR and EU regulatory requirements is required.

Preferred Experience:

1+ years' experience in an IVD or medical device manufacturing environment

Key Skills:

Good knowledge of EU and international regulations.

Good written & verbal communication skills;

Strong time management skills, with the ability to work on multiple projects simultaneously;

Proficiency with Microsoft Office, including Word, Excel, PowerPoint and Visio

Ability to work independently as well as within a team.

Education:

B.S in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience

Interview Process:

Video conference

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.