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 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 industry + Current knowledge of FDA cGMPs, European Medical Device Directive / Regulations, European quality system standards and other Global Markets + Knowledge of commonly used concepts, practices, procedures and business principles within regulatory submissions in a medical device industry + Knowledge of Post Marketing Surveillance regulations + Ability to problem solve, identify errors and deficiencies and perform research with general guidance + Ability to apply knowledge to their job function using pre-established guidelines and instructions + Accuracy, attention to detail, and thoroughness + Proficient computer skills + Proficient communications skills + Ability to comprehend and comply with company safety and quality standards + Ability to follow oral and written instructions Preferred: + RAC certification + Product failure analysis + Product submission experience (domestically and internationally) + Prior strategic experience with regulatory agencies regarding domestic and international product submissions within the medical device industry + Full knowledge of design controls + Experience in manufacturing or with Medical Devices + Experience 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.