Jalex Medical
Published
05/23/2019
Location
Westlake
Category
Job Type
Contact Name
Erin
Street Address
30311 Clemens Rd., Suite #5D
Address Line 2
Suite #5D

Description

JALEX Medical is a consulting firm that provides engineering, quality, and regulatory services to the medical industry. We have mechanical engineers, biomedical engineers, material specialists, and quality and regulatory specialists.

This position involves all aspects of Quality and Regulatory, including customer consultation, marketing support, design and development support from a regulatory standpoint, and post launch surveillance for our customers.

Qualifications: 

  • Bachelor’s Degree in Engineering, Science, or health-related field
  • 3-5 years related work experience
  • Working knowledge of FDA and other regulatory authorities
  • FDA Regulatory submission experience (510ks, PMAs, IDEs)
  • Quality Systems development, implementation, and training experience
  • International submission experience (CE Mark, MDL, MDEL)
  • Experience with ISO 13485, FDA, MDR (Medical Device Regulation), and CMDD (Canadian Directive) compliance requirements and training
  • Experience with Risk Management per ISO 14971
  • Experience with FDA remediation, Warning Letters, 483 Observations, and Recalls a plus
  • Candidate must be a self-starter, self-motivated, and results oriented
  • Excellent interpersonal and written communication skills
  • Must be able to work independently and have ability to work with cross-functional teams
  • Extensive project management skills with the ability to work under tight timelines and able to multi-task

Responsibilities: 

  • Assist with premarket FDA and international regulatory submissions
  • Assist with development and/or revision of Quality System procedures and processes
  • Assist with internal and supplier audit development, implementation, and execution
  • Serve as a company representative during external audits by Regulatory and Third Party Auditors
  • Design Control documentation assistance
  • Validation and Testing Protocol Development
  • Perform gap assessments against new and revised Quality Modules, Quality Directives, and ISO requirements

Benefits of Employment

    • Competitive Base Salary plus Bonus plan
    • Benefits: Medical, Dental, Vision, Life Insurance, STD/LTD, 401(k) match, 10 PTO days, 12 Paid Holidays, Summer Hours, Wellness Program with Gym Membership
    • Company cell phone and laptop
    • Training and support in developing your understanding of medical device development and regulatory/quality solutions
    • Exciting, fast-paced, and team-oriented culture with fun company outings and team building activities
    • Opportunity to get in on a growing, enthusiastic company and establish yourself as a long-term key member
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