Regulatory Affairs Specialist (12-Month Contract)

Akkodis; Scarborough (ME); Sur place; USD 39 000 - 41 000; Plein temps

Avantages offerts par ce poste

Medical coverage

Dental coverage

Vision coverage

Life insurance

Short-term disability

401K plan

Paid leave

Résumé du poste

Akkodis is seeking a Regulatory Affairs Specialist for a 12-month contract position located in Scarborough, ME. The role offers the chance to work in a primarily independent, work-from-home friendly environment with production expectations.

Responsibilities include supporting the quality system, guiding regulatory activities, and preparing submissions for US and international regulators. Bachelor’s degree and related experience required.

Qualifications

• Bachelor's degree in biology, chemistry, biochemistry, engineering or related technical field or equivalent combination of education and experience.

Responsabilités

• Responsible for implementing and maintaining the effectiveness of the quality system in daily operations.
• Provides regulatory direction and interpretation on team activities and product development.
• Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies.
• Handles regulatory activities involved in documentation, labeling, field support, and change control.
• Maintains compliance with the quality system and site/division policies.

Formation

Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or related field

Description du poste

Akkodis is seeking a Regulatory Affairs Specialist for a 12-month contract position located in Scarborough, ME. The role offers the chance to work in a primarily independent, work-from-home friendly environment with production expectations.

Responsibilities include supporting the quality system, guiding regulatory activities, and preparing submissions for US and international regulators. Bachelor’s degree and related experience required.