Connexion Systems + Engineering
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Regulatory Affairs Specialist
Tewksbury, MA 01810 US
Posted: 02/23/2023
2023-02-23
2023-10-26
Industry: Scientific and Life Sciences
Job Number: 15371
Job Description
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: Regulatory Affairs Specialist
Hiring Organization: Connexion Systems & Engineering
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
EDUCATION:
• 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.
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!
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
EDUCATION:
• 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.
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!
