Regulatory Affairs Manager at Spectrum Plastics Group in Tucson, Arizona

Posted in Manufacturing about 2 hours ago.

Type: Full-Time





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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