Regulatory Affairs Associate

Akkodis; Scarborough (ME); On-site; USD 39,000 - 41,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Short-term disability

401K plan

Paid leave

Job summary

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.

Responsibilities

• 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.

Education

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

Job description

Akkodis is seeking a Regulatory Affairs Specialist for a 12 Months contract position with a client located in Scarborough, ME. Ability to Work Independently - must be able to stay focused, on tasks, and meet HOURLY production expectations in a WFH environment comes as a plus.

Job Title : Regulatory Affairs Specialist

Location : Scarborough, ME

Duration : 12 Months

Pay Range: $28/hour - $30/hour. The rate may be negotiable based on experience, education, geographic location, and other factors.

Basic Qualifications | Education:

• Bachelor's Degree in Biology, Chemistry, Biochemistry, Engineering or other related technical field or the equivalent combination of education and experience.

Duties:

• Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day to day activities for change control.
• Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities.
• Interprets and applies regulatory understanding to support of products and teams.
• Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
• Handles regulatory activities involved in documentation, labeling, field support. Applies regulatory and technical knowledge to a wide variety of complex work assignments.
• Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.
• Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers