Regulatory Affairs Specialist
Tewksbury, MA 01810 US
Title: Regulatory Affairs Specialist
Hiring Organization: Connexion Systems & Engineering
- Duration: Temp to Perm
- Pay rate: $40-70/hr
- Job Location: Tewksbury, MA
- Job# 15371
Due to rapid growth, we are currently looking for a Regulatory Affairs Specialist to join our team. If you are looking for a hands-on, forward-thinking and fast paced entrepreneurial culture, you thrive on challenges, and are interested in furthering your career, we want to talk to you!
ESSENTIAL JOB DUTIES AND RESPONSIBILITIES INCLUDE:
• Prepare and maintain regulatory submissions and registration of complex Class III devices in the US and in international markets
• Maintain documentation and perform project management tasks, including record keeping and tracking due dates for FDA and international regulatory submissions.
• Assist with the preparation of FDA applications and other international regulatory documents, including EU Technical Files and documentation related to EU MDR certification
• Assist with vigilance reporting in the US and around the world
• Serve as liaison with Quality and Engineering team members and provide support with FDA and EU regulations; participation in FDA and notified body audits as required
BACKGROUND AND QUALIFICATIONS:
• 2+ years regulatory experience in the medical device industry with a proven record of successful regulatory submissions (Class III experience preferred but not required)
• Ability to communicate ideas and information clearly, effectively and frequently (oral and written)
• Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results
• Ability to act independently to determine methods and procedures
• Must be detail oriented with strong organizational skills
• Must have strong interpersonal skills with willingness to be held accountable for deliverables
• Ability to utilize effective analytical and decision making skills
• Proven track record of working in a fast-paced environment with demonstrated ability to adjust to changing priorities
• Bachelor’s in Engineering, Life or Biological Sciences, or related field, MS a plus
Please use the apply button to submit your resume for consideration. A Connexion Representative will contact you immediately.
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