Director of Regulator Affairs
Tewksbury, MA 01810 US
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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
- BS in Engineering, Life or Biological Sciences, or related field; MS preferred
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