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Regulatory Manager – Labeling Design Team
| Company | IDEXX |
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| Location | Portland, ME, USA |
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| Salary | $120000 – $120000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- Bachelor’s degree with 5-7 years of experience in regulatory labeling or equivalent combination of education and experience required.
- 5+ year of demonstrated skills and ability in people management is required
- Ability to organize, prioritize and direct regulatory-based work activities
- You have excellent customer service and business relationship-building skills
- You demonstrate reasoning, problem solving, and analytical skills to resolve issues
- You have project management experience
- You have strong verbal and written communication skills
- You are comfortable working in a cross-cultural work environment
Responsibilities
- Manage a team responsible for the overall process of the creation, approval, regulatory submission, and implementation of labels and inserts for diagnostic test kits manufactured in North America and Europe.
- Coordinate and prioritize all artwork changes within the team and communicate with internal stakeholders in a timely manner.
- Represent Regulatory Affairs on new product development as well as product support teams and provide guidance related to US and global labeling requirements.
- Routinely interact with regulatory officials regarding USDA regulations for label and insert content.
- Participate in large cross-functional projects where product labeling is impacted.
- Work closely with Product Compliance, Employee Health & Safety, and global regulatory colleagues to ensure ongoing compliance.
Preferred Qualifications
- Experience with in-vitro diagnostics, including specific USDA regulatory knowledge is desired
- Some travel may be required
