Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

Title: Director of Regulatory Affairs

Hiring Organization: Connexion Systems & Engineering

• Duration: Perm
• Pay rate: $180-200K
• Job Location: Tewksbury, MA
• Job# 14981

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES INCLUDE:

• Develop strategies and tactics to obtain FDA and international regulatory approvals of marketing applications and clinical trial applications in the US and around the world.
• Prepare and review regulatory submissions for the FDA and international agencies and notified bodies.

• Serve as contact person for regulatory submissions and interact with FDA and international regulatory authorities
• Review and interpret regulatory rules as they relate to company procedures, clinical studies, engineering testing, and documentation and ensure that they are communicated through company policies and procedures
• Review and approve changes to manufacturing processes and products to ensure compliance with US and international requirements
• Serve on product development and engineering teams to ensure that RA requirements are fully understood and addressed as part of the product development and the engineering change process
• Participate in FDA and notified body audits for MDR, MDSAP, and QSR and BIMO compliance
• Manage and mentor junior RA staff members to allow them to become self-sufficient in efficiently completing their RA tasks
• Establish effective communication with executives and managers to ensure that company objectives and regulatory requirements are met
• Enhance and sustain positive relationships with the FDA and other international regulatory agencies and notified bodies.

• BACKGROUND AND QUALIFICATIONS:
• Minimum 10+ years regulatory experience in the medical device industry. Experience with Class III devices in the US and experience/knowledge of EU MDD/MDR required.
• Minimum 2 years management experience required.
• Solid experience and proven track record in successful international (especially EU) and FDA submissions
• Proven project management and leadership skills
• Ability to communicate ideas and information clearly, effectively and frequently (oral and written)
• Ability to exercise independent judgment and to act independently to obtain results
• Detail oriented with strong organizational skills
  • Strong interpersonal skills with willingness to be held accountable for deliverables
  • Proven track record of working hands-on in a fast-paced environment with demonstrated ability to adjust to changing priorities
  • Management experience preferred

EDUCATION:

• BS in Engineering, Life or Biological Sciences, or related field; MS preferred

Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.

When responding to this job posting you MUST include the Job# and Job Title in your subject line.

If you are active in a job search but this job is not for you, please reach out to . We would be glad to help you find the perfect job!