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Position Title:

Regulatory Affairs Associate Work Location:

South Portland, ME 04106

Assignment Duration:

12 Months (Possibility of Extension)

Work Schedule:

7:00 AM - 4:30 PM, Monday -

Friday Work Arrangement:

Onsite Position Summary 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. Key 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 presubmission 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.

Postmarket:

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 postmarket 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. Qualification & Experience
• Technical Diploma (high school or equivalent)
• Minimum 1 year experience Additional Information
• This is an entry level position regardless of the job description implying a higher level of knowledge/competency.
• +/- 1 year work experience.
• Lower-level role in Regulatory Affairs supporting the IVDR group.
• Approved for one year from the start date with possibility of extension.