Regulatory Affairs Project Manager
2 weeks ago
Position: Regulatory Affairs Project Manager
Company: Intellectt Inc
Location: Santa Clara, CA
Job Overview:
- Education: A Bachelor's degree is mandatory; a Master's degree is advantageous.
- Experience: At least 3 years of relevant experience is essential.
- Skills: Familiarity with US and/or Canadian regulations concerning product and/or device approval (FDA) is required.
Key Responsibilities:
- Collaborate in the formulation and execution of regulatory strategies and priorities alongside management, colleagues, commercial teams, and affiliate personnel.
- Effectively communicate issues to management through project management tracking and issue briefings.
- This role holds significant visibility with both internal and external stakeholders.
- Exhibit a high level of effective verbal and written communication skills, demonstrating the ability to negotiate, influence, and resolve conflicts.
- Prior experience in regulatory affairs within the medical device, food, dietary supplement, or pharmaceutical sectors is highly preferred, though not mandatory.
- Work collaboratively, decisively, and collegially with internal clients (scientists, marketing, quality assurance, product development, affiliates) to address challenges and convey regulatory requirements.
- Manage and monitor broad and strategic projects effectively.
- Deliver clear and concise written communications, including briefings and issue analyses.
- Show a proven ability to work efficiently within a team environment.
- Accountable for tracking and ensuring the timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities.
- Responsible for effectively communicating regulatory requirements to project teams and internal stakeholders.
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