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Our client is an innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, they continue to expand their reach, as well as their product offerings. Hospitals, emergency medical services (EMS), and others trust them to provide high-quality products and exceptional customer service.
b Summary
Responsible for preparing regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.
Essential Functions
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Regulatory Affairs Coordinator
2024-10-28
2025-01-11
Employment Type:
Contract
Industry: Professional/Administrative
Job Number: 61417
Office Location: Salem
Job Description
Our client is an innovation-driven company on the forefront of delivering medical devices to save lives, and software solutions to improve efficiency. With customers in more than 140 countries, they continue to expand their reach, as well as their product offerings. Hospitals, emergency medical services (EMS), and others trust them to provide high-quality products and exceptional customer service.
b Summary
Responsible for preparing regulatory submissions required to market new or modified devices in both domestic and international markets including all relevant maintenance activities.
Essential Functions
- Supports in developing partnerships with quality assurance, manufacturing, program management, product development, and marketing to ensure product compliance and timely product clearances and/or approvals.
- Represent regulatory affairs on project/product teams, risk management, and all design review meetings.
- Working with department management provides regulatory guidance and guidance on applicable standards to cross-functional groups
- Working with department management provides global regulatory strategies and regulatory plans
-
Required/Preferred Education and Experience
- Degree in Regulatory Affairs or Regulatory Affairs Certification preferred
- Experience with medical device regulatory submissions (510(k) or PMA preferred
- Experience with medical device submissions preferred
- Commissioned Notary Public in the state of Massachusetts.
-
Knowledge, Skills and Abilities
- Project management skills
- Must be able to work under pressure to meet regulatory reporting time frames and company requirements
- Must be able to work with minimal supervision, recognize departmental needs and initiate/recommend actions for resolution
- Knowledge of U.S. and European/International regulations and standards
- Experience interacting with FDA and/or other regulatory agencies
- Must work well in team environments
- Must demonstrate leadership skills in team setting.
- Proven analytical abilities, Able to apply problem-solving skills for problems of moderate to diverse scope
- Solid understanding of manufacturing and change control, and an awareness of regulatory trends
- Understanding of engineering concepts and scientific terminology
- Superior interpersonal skills
- Excellent communication skills, both oral and written
- Proven ability to prioritize, conduct, and manage time to meet project deadlines
- Documented evidence of writing skills
- Basic understanding of computer applications-Strong knowledge of Microsoft Office package, Windows and e-mail systems. Working knowledge of desktop computer and other software programs
- Familiarity with medical terminology a plus
- Working with department management, communicates with US FDA
- Coordinates/prepare and maintains FDA PMA and 510(k) Premarket Notifications in accordance with US FDA requirements
- Supports Reviews of product labeling changes
- Support CAPA and CAPA closure
- Participates in regulatory audits/inspections as required
- Perform other duties as assigned
Don't feel you are the best fit for this job but know someone who is? Refer someone who is hired for this role (or ANY other) and we will offer you a referral bonus for helping us to keep our client happy.
Please be sure to sign up for email notifications when we post a new opening or check back with http://jobs.techneeds.com to see our list of other openings.
Job Requirements
Support, Admin, Microsoft, data entry
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