RAQA Specialist

TeDan Surgical Innovations (TSI) designs and manufactures specialty surgical products for use in orthopedic, neuro, thoracic and spine surgeries. TSI was founded in 2006 with the goal to innovate and address evolving retraction techniques in spine surgery. We have successfully addressed the need for minimally invasive, posterior, lateral and anterior surgical approaches to the spine, and have introduced access instrumentation for neurological, orthopedic and cardiothoracic procedures. We commit to providing innovative, high-quality surgical access systems designed to optimize exposure and improve the surgeon experience.

Job Summary:

Research and provide recommendations to product teams on appropriate regulatory pathways to market. Participate in teams to ensure appropriate global regulatory requirements are incorporated as part of the development and design changes process for both new and existing products. Research, author or otherwise provide support for regulatory. Coordinate with Notified Bodies, Competent Authorities and other regulatory agencies on submissions, audits, approvals or other issues. Interpret existing and/or new regulatory requirements as they relate to products and procedures and communicate this to personnel. Provide marketing and literature review pre and post market. Research, author or otherwise provide support in preparation and updates to Technical Files. Assist with the development, implementation and maintenance of regulatory SOP’s and development/improvement of processes and procedures. May also be asked to participate in RA related parts in site audits and routine RA maintenance activities. Some travel may be required. Participate in other duties as assigned.

Duties/Essential Job Functions:

• Independent self-starter who is capable of planning and executing schedules, control plans and leading projects as assigned
• Develop and maintain product registrations worldwide (ie. 510(k), EU MDR Technical Documentation, Canadian Licenses and International Submissions)
• Maintain regulatory license renewals and annual registrations
• Serve as core team member of RA/QA for project development life cycle
• Represent RAQA in external and internal audits
• Responsible for generating technical reports (ie. protocol, report, evaluations)
• Review and approve labeling and marketing/training materials
• Assist with resolution of product and process defects as determined through failure analysis, focusing on root cause analysis and implementation of effective corrective action
• Other responsibilities assigned by supervisor associated with role as RA/QA Specialist I, II, III professional

Experience/Skills:

• Work experience in a regulatory affairs/quality assurance position within the Medical Device industry
• Specialist I: 0-5 years
• Specialist II: 5-10 years, depending on scope of responsibility
• Specialist III: 5-15 years, depending on scope of responsibility
• Knowledge and experience with applicable international regulations and standards (CFR, MDD, MDR, QSR, ISO 13485, MDSAP, etc.)
• Demonstrated experience with USA (federal, state, and local) and International product registrations (CFG’s, apostille and consularization processes)
• Good knowledge of product development and processes in Medical Device Industry
• Demonstrated experience with regulatory audits and inspections
• Knowledge of USA and International medical device import and export requirements
• Strong technical writing skills and demonstrated ability creating reports, SOPs, etc., with proficiency in Microsoft Word and Excel programs.
• Demonstrated strong organization analytical skills with keen attention to detail
• Communication: Ability to internally and externally communicate verbally and in writing -initiating discussions, clearly defining key issues and independently develop course of action/plans
• Interpersonal: Ability to cooperate and support team members; coordinate interdepartmental activities; and, positively resolve individual conflicts and issues
• Business Acumen: Require a basic understanding of business and financial impact of project
• Teamwork: Ability to work independently or in a team environment; pursue trust for each team member; seek and deliver honest feedback with team members; committed and accountable to achieving team goals; abide by team decisions.

Required Education/Licensing/Certification:

• Specialist I: Highschool diploma or equivalent; college degree preferred
• Specialist II, III: College degree in sciences and/or relevant work experience

Physical Requirements:

• Business casual attire.
• Occasionally requires attending corporate functions
• Occasionally may require travel (5-10%).