Regulatory

Regulatory Affairs Coordinator

About the Job:
SpineCraft develops, manufactures and distributes a growing line of spine surgery implants & instruments systems that provide comprehensive solutions to improve and enhance quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.

We are looking for a Regulatory Affairs Coordinator to join our growing team in Westmont, IL.

Essential Job Duties and Responsibilities:
  • Assist in review, analysis, understanding, and recommendation of product registration requirements by country.
  • Assist in review and evaluation of changes in worldwide regulatory requirements.
  • Working with internal resources and external specialists, assist in managing the timely dissemination of documentation necessary for product registration in markets where products are to be sold.
  • Assist in review of changes to existing products and Quality System procedures to define requirements for regulatory submissions.
  • Assist in evaluating regulatory compliance of document/product/process/test method changes.
  • Analyze and disseminate regulatory information to Production/Contract-manufacturers, QA, and R&D, and Senior Management as needed.
  • Assist in adding to and maintaining library of generally required technical documentation of product registration and maintaining status of each registration file by country.
  • Assist in interfacing “externally” with customers, domestic and foreign government offices, contract-manufacturers, and “internally” with departments within as Product Development, QC, Packaging and Labeling.
  • Obtain Free Sale Certificates and Country specific Declarations.
  • Assist in review, analysis and submission of customer complaints to appropriate regulatory agencies.
  • Act as liaison with groups who perform additional investigation and who prepare written record of investigation.
  • Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.
  • Assist in review and interpretation of risk management documentation as it applies to the complaint event.
  • Ability and willingness to work over-time (after 5:00p.m.) as dictated by business needs.

Skills and Qualifications:
  • Bachelor’s degree in Life Sciences or Engineering, or equivalent in education and experience.
  • 2-3 years of medical device regulatory experience.
  • Follow-through skills and strong attention to detail a must.
  • Must be highly organized and able to prioritize with minimal supervision.
  • Self-motivated with a strong sense of ownership in areas of responsibility.
  • Proficient with Microsoft Office and technical writing.
  • Must be able to work independently, have excellent oral & written communication skills.
  • Ability to process and track a high volume of information and assignments.
  • Ability to understand the functionality / intended use of complex medical devices.
  • 2+ years of experience in research and development involving orthopedic implants preferred.
  • Experience in Medical Device manufacturing environment preferred.
  • Knowledge of FDA and EU regulations is preferred.
  • ISO 13485 certification is preferred.

SpineCraft offers a generous compensation and benefits package that includes comprehensive medical, dental, and vision insurance benefits plus a 401K retirement plan.
Interested candidates may email their resumes to careers@spinecraft.com with a copy to hr@spinecraft.com
Senior Regulatory Affairs Specialist

About the Job:
SpineCraft develops, manufactures and distributes a growing line of spine surgery implants & instruments systems that provide comprehensive solutions to improve and enhance quality of life for patients with back pain, neck pain, degenerative disc conditions, spine deformities and injuries due to trauma.

We are looking for a Senior Regulatory Affairs Specialist to join our growing team in Westmont, IL. Successful candidate will be responsible for assisting with products registration in the US and other international markets and will provide support for the company product registration based on regulatory requirements by country.

Reports to:
VP of Regulatory Affairs & Quality Assurance

Minimum Qualifications and Experience Requirements:
  • Master’s degree in Life Sciences or Engineering, or equivalent in education and experience
  • 5 years of medical device regulatory experience
  • Knowledge of FDA and EU regulations
  • Proficient with Microsoft Office and technical writing
  • Excellent verbal and written communication skills.
  • Experience with managing projects of different complexities.
  • Ability to understand the functionality / intended use of complex medical devices.
  • 4+ years of experience in research and development involving orthopedic implants.
  • Experience in Medical Device manufacturing environment preferred.
  • ISO 13485 certification is preferred.
  • Experience with implementing Unique Device Identifier (UDI) preferred.

Job Duties:
  • Review, analysis, understanding, and recommendation of product registration requirements by country.
  • Review and evaluate changes in worldwide regulatory requirements.
  • Working with internal resources and external specialists, manages the timely dissemination of documentation necessary for product registration in markets where products are to be sold.
  • Assist in review of changes to existing products and Quality System procedures to define requirements for regulatory submissions.
  • Evaluate regulatory compliance of document/product/process/test method changes
  • Analyzed and disseminated regulatory information to Production/Contract-manufacturers, QA, and R&D, and Senior Management as needed.
  • Add to and maintain library of generally required technical documentation of product registration and maintaining status of each registration file by country.
  • Interface “externally” with regulatory firms, customers, domestic and foreign government offices, contract-manufacturers, and “internally” with departments within as Product Development, QC, Packaging and Labeling.
  • Obtain Free Sale Certificates and Country specific Declarations.
  • Maintain external references, lists of national and international regulation standards and FDA guidance documents that affect the products and operations.
  • Review, analyze and submit customer complaints to appropriate regulatory agencies.
  • Act as liaison with groups who perform additional investigation and who prepare written record of investigation.
  • Interact with Technical Service, Manufacturing, R&D, and Quality Assurance, as needed, during the course of complaint processing.
  • Provide basic technical expertise and assistance in handling complaints to comply with current FDA and International reporting regulations.
  • Reviews and interprets risk management documentation as it applies to the complaint event.

SpineCraft offers a generous compensation and benefits package that includes comprehensive medical, dental, and vision insurance benefits plus a 401K retirement plan.
Interested candidates may email their resumes to careers@spinecraft.com with a copy to hr@spinecraft.com