Regulatory Affairs Associate

Akkodis is seeking a Regulatory Affairs Associate for 12-month contract with a client in South Portland ME 04106

Position: Regulatory Affairs Associate

Location: South Portland ME 04106

Duration: 12 months contract

Pay Range: $18 - $20/hr. (The rate may be negotiable based on experience, education, geographic location, and other factors.)

Summary

Experienced para-professional individual contributor working under limited supervision within the Regulatory Affairs sub-function.

Applies subject matter knowledge in Regulatory Affairs.

Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

Main Responsibilities

• As the Experienced para-professional in the Regulatory Affairs Sub-Function, possesses specialized knowledge in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
• Strategic Planning: Assist in SOP development, review and initiation; Stay abreast of regulatory procedures and changes in regulatory climate and update department; Investigate regulatory history of similar products to assess approval implications; Conduct research on submission requirements and options; Assist in monitoring and reporting project timelines; Respond to regulatory information requests; and Monitor and utilize tracking and control systems.
• Premarket: Compile and organize materials for resubmission reports; Coordinate and assist in the preparation of submission/registration packages; Coordinate registration requests and track completion; Implement submission templates; Oversee quality control of regulatory documents and submissions; and Organize meetings with regulatory agency staff.
• Post market: Update and maintain global product listings, facility registrations, licenses/approvals, and annual registrations; Assist in the preparation of routine reports and regulatory agency communications; Assist in the preparation of post market reports and submissions; Update and maintain paper/electronic document archival systems; Prepare legal documents for import/export, registrations, tenders/bids or other purposes;
• Serves as regulatory liaison throughout product lifecycle.
• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
• Ensures timely approval of new medical devices and continued approval of marketed products.
• Serves as regulatory representative to marketing, research teams.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

Education

Technical Diploma (high school or equivalent)

Equal Opportunity Employer/Veterans/Disabled

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

· San Francisco Fair Chance Ordinance