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Regulatory Affairs Associate

Generis Tek

Job Location:

South Portland, ME - USA

Hourly Salary: USD 20 - 22

Posted: 8 September 2026 (13 hours ago)

Application Deadline: 6 December 2026

Vacancies: 1 Vacancy

Job Summary

Please Contact: To discuss this amazing opportunity reach out to our Talent Acquisition Specialist Dhaval Parmarat email address can be reached on # .

We have Contract role Regulatory Affairs Associate for client at South Portland ME. Please let me know if you or any of your friends would be interested in this position.

Position Details:
Regulatory Affairs Associate- South Portland ME
Location : South Portland ME 04106
Project Duration: 12 Months of contract (Possibility of Extension)
Shift Timings : 7:00 AM to 4:30 PM (Mon to Fri)
Pay Range : $20.00-22.00 per hour on W2

This is an entry level position regardless of the job description implying a higher level of knowledge/competency. 1 year or less work experience this will be a lower-level role in Regulatory Affairs in the IVDR group.

Main Purpose of the Role:
Experienced para-professional individual contributor working under limited supervision within the Regulatory Affairs sub-function. Applies subject matter knowledge in the area of 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 pre submission 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.