Regulatory Engineer - Relocation assistance provided - Job # 2327

Additional Information
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  • Full Scale Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Client Synopsis:

Full Scale Solutions is currently recruiting the following position for our RTP, NC based Client.

We are seeking a Regulatory Engineer who will be responsible for supporting our Clients' product line with regulatory changes and quality improvement activities. The incumbent will work with other department team members to establish and maintain appropriate systems to ensure regulatory compliance consistent with state, federal and international product requirements. The individual will complete product applications for the US, Canada, South America, Europe and many other countries around the world.

Primary Responsibilities:

Responsibilities include, but are not limited to:

  • Provides customer support on regulatory issues.
  • Manages technical aspects of quality issues and problems.
  • Develops and maintains product technical construction files.
  • Develops 510K submissions and obtains FDA approval.
  • Supports product registrations for many countries on a worldwide basis.
  • Provides project leadership for needed updates to existing products caused by new/revised standards.
  • Support worldwide regulatory compliance of company products and/or services, including RoHS, REACH, Risk Management, IEC 60601-1 Third Edition, etc.
  • Work closely with other departments, especially Engineering, to ensure new products are in compliance with published standards.
  • Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
  • Conduct training and/or communicate appropriate material to internal staff to aid in compliance.
  • Assist in developing regulatory affairs internal policies and procedures, and provide compliance training.
  • Other duties as assigned.

Minimum Qualifications:

  • B.S. degree in Electrical Engineering, Biomedical or related field.
  • 4-6 years Regulatory prior experience, medical device industry highly preferred.
  • Extensive knowledge of medical device regulations and standards. (e.g. FDA, MDD, ISO 9001, ISO 13485, etc. ).
  • IEC60601-1 3rd addition.
  • RoHS/REACH experience preferred.
  • Product registration knowledge and experience on a worldwide basis.
  • Excellent organizational and multi tasking skills.
  • Ability to work under pressure with strict deadlines.
  • Detail-oriented.
  • Excellent oral and written communication skills.
  • Good presentation skills.
  • Proficient with MS Office, including MS Word, Excel and PowerPoint.

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