Job Details
Qualifications
- Bachelor of Science
- Bachelor's degree
- Doctoral degree
- FDA regulations
- Master of Business Administration
- Master's degree
- Product development
- Product management
- Project management
- Quality management
Benefits
- 401(k)
- Dental insurance
- Employee discount
- Health insurance
- Stock options
Job Description
Opportunity
AVACEN Medical, is looking for a full-time experienced Product/QMS Manager for our fast-growing business.
If you enjoy working with clever, hardworking, optimistic and fun-loving team members, this is the job for you.
Looking for more responsibility? You grab it and we will support and encourage you all the way!
Our unique, award winning, non-invasive FDA-cleared thermotherapy medical device is changing the world for the better every day.
Military service a plus.
Job Description
Product/QMS Manager
The position reports to the Chief Executive Officer (CEO) and is responsible for driving the development and execution of the commercial marketing strategy for AVACEN’s Thermotherapy Medical, Wellness and Perioperative Devices. The position works closely with the AVACEN senior management team to launch new products or release updates for existing products. The position drives domestic and international regulatory approval, product pricing, competitive research, development of voice of the customer functionality, and other design to market oversight necessary to ensure effective acceptance and demand by customers and its distributor network.
Technical / Functional Skills
Firmware engineering and FDA regulatory experience relevant to medical device development and marketing.
Lead external relationships and engage strategically with, regulators, customers, CROs and KOLs to keep a pulse on market trends and anticipate customer needs
Inspire, motivate and facilitate innovation to enhance product development and physician testing of products in preclinical studies.
An entrepreneurial approach to business and problem solving, leveraging internal/external resources and partnerships.
Drive to conceive, create and advance new product uses.
Key Professional Experiences
Executive presence and business acumen necessary to advance to COO.
Broad understanding of device development and regulatory processes.
Extensive experience and proven track record in leading the development of plans to competitively position products for global regulatory and clinical acceptance.
Expertise in project management.
Proven ability in product design documentation and clinical evidence strategies required for FDA product approval/clearance.
Experience leading external relationships and engaging strategically with, regulators, customers, CROs and KOLs
Advanced understanding of global regulatory requirements and processes governing the development and registration of devices.
Direct experience with relevant regulatory agencies (FDA, Health Canada, etc.)
Experience in the creation and defense of intellectual property
Education Requirement:
BS/BE/BA required, advanced degree preferred (MS/ME, MBA, PhD)
Required:
Training in disciplines relevant to Electrical Engineering.
5-10 years’ experience in medical device development.
5+ years of management experience.
Track record of new product introduction and product life cycle management
Knowledge of regulatory requirements for FDA and international agencies.
Direct experience with FDA QMS design file maintenance
Understanding of Medical Device Product Development
BENEFITS:
Stock Options
401(k)
Dental Insurance
Employee Product Discount
Health Insurance
Life Insurance
Vision Insurance
SCHEDULE:
Primarily Monday to Friday with online weekend meetings as needed and trade show attendance from time to time. Minimal travel.
LOCATION:
Carlsbad, CA
BENEFIT CONDITIONS:
Only full-time employees eligible
Salary commensurate with experience
Job Type: Full-time.
This Company Describes Its Culture as:
- Team-oriented -- cooperative and collaborative
This Job Is:
- A job for which military experienced candidates are encouraged to apply
Visa Sponsorship Potentially Available:
- No: Not providing sponsorship for this job
Work Remotely
- No
Job Type: Full-time
Pay: $75,000.00 - $150,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Employee discount
- Health insurance
- Life insurance
- Vision insurance
Schedule:
- Monday to Friday
- On call
Application Question(s):
- Do you have Medical Device and Regulatory experience?
Work Location: In person