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Sr. Regulatory Affairs Specialist

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Location
MN
Job Type
Direct Hire
Date
Nov 20, 2018
Job ID
2640263
Our mid-sized medical device client has a small office in the southwest suburbs and they are looking to add a Regulatory Specialists.  This person will have the opportunity to work remote 2 days a week.  They have doubled revenue in 36 months. This will be a great opportunity to learn new things and gain new experiences in a smaller, more nimble company.
  • Manage regulatory submissions including registration strategy, timeline and submission coordination, development/review of documentation, submission tracking, and liaison with submitter/regulatory authorities.  Support distributors and business partners in securing and maintaining regulatory clearances.
  • Maintain systems for tracking current projects and for projection of future activity loads.
  • Develop, organize and maintain documentation to support all product marketing approvals, licenses, clearances, registrations and certifications.
  • Maintain Regulatory approval/clearance database for where products are cleared from a Regulatory perspective for distribution.
  • Analyze regulatory environment changes and strategically implement requirements within submission preparations as well as communicates changes effectively throughout the organization. Authors key portions of company responses to proposed standards, directives, policies and legislation regarding company products and systems.
  • Develop and maintain assigned departmental quality system procedures, instructions and provide training as necessary both within and outside the department.
  • Coordinate regulatory aspects (e.g. design, development, review, approval, implementation, control, revision, translation) of the product labeling and promotional materials process, as needed, (e.g. package labels, ancillary labels, package insert, surgical technique, marketing materials) to assure accuracy, consistency and compliance with applicable State, Federal and International regulatory requirements, as well as company and customer requirements.
  • Provide regulatory support to product development and business teams.  This includes preparation of regulatory opinion documents, coordination of labeling activities, as needed, and review /approval of design control documentation, risk management reports, technical protocols/reports and other outputs of product development as appropriate.
  • Provide senior level regulatory expertise consultation and training across the organization, including development of less tenured Regulatory team members.
  • Support all aspects of the quality system, including participation in audits and inspections by regulatory authorities and certification/accreditation bodies.
  • Maintain metrics on regulatory performance and participate in process improvement, departmental and cross-functional projects as assigned.
EDUCATION/EXPERIENCE REQUIRED AND/OR PREFERRED: 
  • BS/BA Degree in relevant technical discipline (Engineering, Science, or medically related)
  • 5+ years relevant device or pharmaceutical regulatory experience, 510k needed
  • Knowledge of FDA medical device and/or tissue regulations, ISO standards and EC directives (93/42/EC) required.
  • AATB CTBS, RAC-EU or US certifications a plus