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.