Thank you for your interest in Focus Surgery. We currently have the following openings:
Director - Regulatory Affairs
Focus Surgery, a pioneer in the development and commercialization of products using High Intensity Focused Ultrasound - HIFU- for the treatment of prostate diseases, is seeking a Director-Regulatory Affairs.
The Director-Regulatory Affairs responsibilities will include:
 |
Develop strategies for regulatory
approval of medical devices
| ||||||||
| Coordinate submission activities for a variety of device regulatory approvals including: US pre market approvals, international technical files/design dossiers, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings; | ||||||||
| Serve as internal consultant on regulatory issues such as IDE's PMA's, product changes, manufacturing changes, recalls, advertising and promotional activities, field actions or review of proposed device changes; | ||||||||
| Lead FDA meetings on the clinical trial activities and PMA submissions; | ||||||||
| Communicate submissions and/or advertising and promotion requirements to internal and external customers such as product development teams, marketing, sales and medical advisors; | ||||||||
| Assist in managing assigned internal and external clinical activities; | ||||||||
| Assist in preparation of regulatory documents and study files; | ||||||||
| Participate in training and mentoring of staff. |
Requirements:
| Bachelors Degree- preferably in Life Sciences or Engineering disciplines (Biomedical); advanced degree highly desirable; |
| 5 - 7 years demonstrated experience in Regulatory (FDA, CE & International) field specifically in medical devices; |
| Knowledge and experience in ultrasound technology is highly desirable; |
| Strong project management experience; |
| Excellent organizational and communications skills |
| Travel requirements: 25 - 40% |
Quality Assurance Manager
Focus Surgery, a pioneer in the development and commercialization of products using High Intensity Focused Ultrasound - HIFU- for the treatment of prostate diseases, is seeking a Quality Assurance Manager.
The Quality Assurance Manager responsibilities will include:
| Maintain, audit and coordinate product assurance program to prevent or eliminate defects in new and existing products; |
| Formulate and maintain quality assurance objectives, and coordinate objectives with production procedures in cooperation with other staff to maximize quality and reliability and minimize costs; |
| Analyze, evaluate and coordinate information concerning factors affecting quality in new and existing products; |
| Facilitate quality system to delineate areas of responsibility, personnel requirements, and operational procedures within program, according to and consistent with company goals and policies; |
| Investigate customer complaints regarding quality and make appropriate adjustments. |
Requirements:
| Bachelors Degree - preferably in Engineering discipline (Electrical, Mechanical, Biomedical) |
| 5 - 10 years demonstrated experience in Quality Assurance/Engineering field as well as ISO 13485 background; |
| Knowledge and experience in ultrasound technology is highly desirable; |
| Experience in Regulatory (FDA, CE & International) area with medical devices is highly desirable; |
| Knowledge of manufacturing processes |
| Project Management experience |
Focus Surgery is committed to providing team members with:
|
A dynamic, engaging work environment |
|
Opportunities for career growth |
|
Industry competitive compensation packages |
|
A wide range of benefits including health, dental, vision and 401(k) |
|
Flexible work schedules and time off plans |
|
A comfortable, business casual work environment |
Let us know if you want to be part of the team!
Please send all inquiries and/or resumes to the following address:
Focus Surgery, Inc.
3940 Pendleton Way
Indianapolis, IN 46226
Tel: (317) 541-1580
Fax: (317) 541-1581
or by email to: HR@focus-surgery.com
If you are submitting a resume, please be sure to include a cover letter.
The Sonablate® is an investigational device limited by Federal Law to investigational use in the United States.