Careers at Hansen Medical
Regulatory Associate
SUMMARY:
The Regulatory Associate has responsibility for preparing and submitting domestic and international regulatory submissions. He/she is also responsible for writing modification documentation and reviewing labeling to ensure compliance with regulatory requirements. Amount of independence provided dependent on experience and demonstrated work product.
PRINCIPAL DUTIES:
- Prepare and submit 510(k)s and letters-to-file
- Prepare technical files and design dossiers for class IIa and class III products
- Prepare and submit applications for foreign (non-EU) device registration
- Review labeling and advertising to ensure compliance with FDA requirements
- Provide regulatory guidance and support to project core teams
- Participate in development of regulatory strategies
REQUIREMENTS:
Experience: 2 years minimum of documented success in regulatory affairs for a medical device company. Experience with catheter based products highly desired. Experience with 510(k) and IDE submissions required. Experience with PMA submissions highly desired. Thorough understanding of FDA and international regulations required.
Education: A minimum of a BS degree in a scientific discipline such as engineering, physics, chemistry, biology or biochemistry.
Special Skills/Abilities: Attention to detail and accuracy, excellent oral and written communication skills, demonstrated proficiency to respond effectively to meet management objectives, self-motivated, and possess professional ethics, excellent planning and organizational skills, strong interpersonal /group skills, capable of working collaboratively with colleagues in all functions, ability to understand and comply with domestic and international regulatory requirements.
Please submit your information to: recruiting@hansenmedical.com
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