Regulatory Affairs Specialist
1 week ago
We are seeking a highly skilled Regulatory Affairs Specialist to provide direct Worldwide Regulatory support to various projects and products.
Key Responsibilities:- Support strategic planning and product development efforts by providing Regulatory guidance and expertise.
- Prepare and submit Regulatory documents to the FDA and other Regulatory agencies, including international documents.
- Coordinate and complete submissions, respond to Regulatory correspondence, and conduct product labeling and advertising review and approvals.
- Evaluate proposed product modifications for Regulatory impact and complete Regulatory Assessments as needed.
- Liaise with project teams, including Core Team membership, to ensure effective Regulatory support.
- Knowledge of Medical Device Regulatory, FDA regulations, CE and ISO requirements.
- Excellent communication skills, both verbal and written.
- Good organizational skills and analytical thinking, problem-solving, and investigative skills.
- Required experience: 1 to 3 years in Medical Device quality control and regulatory affairs.
A competitive estimated salary of $80,000 per year, depending on experience, and opportunities for professional growth and development.
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