JOB PURPOSE: Provide management controls and ensure regulatory compliance requirements are met for all products produced at the Spectrum Plastics Group Tucson site.
ESSENTIAL DUTIES: Represent RA in design teams and projects by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions currently under review. Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues. Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes. Coordinate efforts associated with the preparation of regulatory documents or submissions.Coordinate, prepare, and/or review regulatory submissions for domestic or international project and host outside regulatory agencies.Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.Prepare or maintain technical files as necessary to obtain and sustain product approval. Submit notification to Notified Body about significant changes to CE marked products in a timely manner.Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.Analyze the input of cumulative product changes to current product submissions.Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Identify relevant regulations, international standards, consensus standards or guidance documents and provide interpretive assistance. Interpret regulatory rules or rule changes and ensure that they are communicated to RA/QA and Development personnel. Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis. Maintain annual licenses, registrations, listings and patent information.Participate in the development of a strategic plan to define the company business direction into the future.Oversee a team of people, ensuring their growth and development and their ability to meet SPG performance standards.Uphold SPG vision, Quality Policy, and core values.Coordinate with other departments to ensure projects are completed on task.Perform other duties as required. QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities) Required: Applicable Bachelor's degree and/or equivalent experience in a related field, and a minimum of 5 years directly related to Regulatory Affairs experience in the medical device industryCurrent knowledge of FDA cGMPs, European Medical Device Directive / Regulations, European quality system standards and other Global MarketsKnowledge of commonly used concepts, practices, procedures and business principles within regulatory submissions in a medical device industryKnowledge of Post Marketing Surveillance regulationsAbility to problem solve, identify errors and deficiencies and perform research with general guidanceAbility to apply knowledge to their job function using pre-established guidelines and instructionsAccuracy, attention to detail, and thoroughnessProficient computer skills Proficient communications skillsAbility to comprehend and comply with company safety and quality standardsAbility to follow oral and written instructions Preferred: RAC certificationProduct failure analysisProduct submission experience (domestically and internationally)Prior strategic experience with regulatory agencies regarding domestic and international product submissions within the medical device industryFull knowledge of design controlsExperience in manufacturing or with Medical DevicesExperience with Lean Manufacturing WORKING CONDITIONS: Requires light physical activity performing non-strenuous activities of a decision-making nature. Requires moderate periods of sitting, using a computer, as well as periods of standing and walking around the manufacturing facility where protective clothing might be required as deemed necessary. In addition, it is necessary to attend occasional management/project meetings.