LipoSonix, Inc.

Regulatory Affairs Manager

The position will be primarily responsible for developing and influencing regulatory policy as well as the creation, preparation, and achievement of regulatory submissions and approvals of complex electronic products.

Primary responsibilities will include:

• Planning, coordination and preparation of FDA submissions for products as required for timely clinical studies and market releases.
• Establishing and maintaining corporate electronic document packages compliant with 21 CFR 11 requirements appropriate for regulatory submissions, including FDA IDEs, 510(k), PMAs, CTDs, and Design Dossiers.
• Processing foreign registrations and obtaining Permission to Export for ex-US clinical trials.
• Maintain regulatory submission correspondence files and other electronic document files in a complete and secure manner.
• Review and approve document change orders that may impact regulatory submissions and approvals, including design and manufacturing changes, labeling, etc.
• Maintain annual facility registration and device-listing documents.
• Review and approve software verification and validation protocols to support regulatory submissions.
• Review and approve test protocols and reports to support regulatory submissions.
• Provide project, department, and company guidance and training based on current and emerging regulatory affairs requirements, regulations, and processes, including Quality Systems Regulations and Design Control.

Position requirements include:

• Strong regulatory affairs experience related to complex electronic medical devices.
• Good knowledge of FDA medical device regulations and guidance.
• Familiarity with medical device labeling and promotional requirements.
• Successful original 510(k), IDE and/or PMA submissions.
• Proficient in timely review of technical and clinical data.
• A self-motivated and results-oriented individual.
• Good presentation skills, able to work in a team and small company environment, ability to accomplish multiple assignments simultaneously.

Desired skills include:

• Background in diagnostic or therapeutic ultrasound.
• Background in statistical analysis.

Applicants should have a BS/MS degree or equivalent in Life Sciences and 5 years relevant experience.

Submit a resume today to:

LipoSonix, Inc.
Attn: Human Resources
PO Box 1676
Bothell, WA 98041-1676
Email: careers@liposonix.com

LipoSonix, Inc. is an Equal Opportunity Employer

Submitted: 07/28/2004