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.