Job description

Regulatory Affairs Specialist - US / EU

Covid Vaccination Needed

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

Job Types: Full-time, Contract

Pay: $40.00 - $50.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Paid time off

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work Location: One location

jackharris.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, jackharris.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, jackharris.com is the ideal place to find your next job.