Regulatory Affairs Specialist II

Description

JOB PURPOSE: 

Provide support for the regulatory department to ensure efficient and compliant business processes and environment.  The individual will execute tasks and play a consultative role by partnering across business functions.  The individual will assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide.  The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

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, or review regulatory submissions for domestic or international projects.
• 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 and submit post-market medical device reports, vigilance reports, and other adverse event or field action reports/notices as necessary.
• 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 other personnel as applicable.
• Responsible for writing and updating standard operating procedures (SOP), work instructions (WI), and policies on an as-needed basis.
• Maintain annual licenses, registrations, and listings information.

• Upholds XERIDIEM vision, Quality Policy, and core values.
• Coordinates with other departments to ensure projects are completed on task.
• Coordinate tasks of others within projects.
• Communicates with customers and vendors as needed.
• Performs a variety of tasks using experience and judgment.
• Performs 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 3 years directly related to Regulatory Affairs experience in the medical device industry.
• Current knowledge of FDA cGMPs, European Medical Device Directive (MDD)/Medical Device Regulation (MDR), European quality system standards and other Global Market regulations.
• Has knowledge of commonly used concepts, practices, procedures and business principles within regulatory submissions in the medical device industry.
• Has knowledge of Post Marketing Surveillance regulations.
• Has knowledge of commonly used concepts, practices, and procedures within field.
• Ability to problem-solve, identify errors and deficiencies, and perform research with limited 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
• A certain degree of creativity and latitude
• Ability to comprehend and comply with company safety and quality standards
• Ability to follow oral and written instructions

Preferred:

• Product failure analysis
• RAC certification
• 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.