Regulatory Affairs Manager Job at Spectrum Plastics Group, A DuPont Business, Tucson, AZ

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  • Spectrum Plastics Group, A DuPont Business
  • Tucson, AZ

Job Description

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 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.

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