Regulatory Affairs Associate

We are looking for Regulatory Affairs Associate for our client in Portland, ME

Job Title: Regulatory Affairs Associate

Job Location: Portland, ME

Job Type: Contract

Job Overview:

Pay Range: $15.53hr - $20.53hr

Requirement/Must Have:

• 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.
• Possesses specialized knowledge in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

Responsibilities:

• 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.
• 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.
• Organize meetings with regulatory agency staff.
• 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.
• Serve as regulatory liaison throughout product lifecycle.
• Participate in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
• Ensure timely approval of new medical devices and continued approval of marketed products.
• Serve as regulatory representative to marketing and research teams.
• Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

Skills:

• Regulatory Affairs.
• SOP development.
• Product registration submission.
• Premarket submissions.
• Postmarket reports.
• Chemistry manufacturing control (CMC).
• Risk management.
• Technical labeling.

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities