Regulatory Affairs Specialist jobs in Fort Wayne, IN

SUMMARY: The position of QARA Specialist is responsible for planning, directing, and/or coordinating regulatory affairs activities of Red Star Contract Manufacturing to ensure compliance with regulations and standard operating procedures. Additionally, the position will support special projects, such as PFMEA maintenance, internal/external audits, and other items as assigned by quality management.

ESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)

• Develop regulatory strategies and implementation plans for the preparation and submission of new products.
• Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. Monitor organization procedures to ensure proper functioning.
• Manage and/or participate in activities such as audits, regulatory agency inspections, or product recalls.
• Maintain current knowledge of relevant regulations, including proposed and final rules, to determine potential impacts on organizational processes.
• Direct documentation efforts to ensure compliance with domestic and international regulations and standards.
• Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
• Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
• Provide responses to regulatory agencies regarding product information or issues.
• Coordinating and/or creating all documents required for a DMR, including control plans, PFMEAs, process specifications, capability studies, and other items required by the customer for the NPI launch.

QUALIFICATION REQUIREMENTS:

• Bachelor's Degree or equivalent is required.
• A minimum of 6 years of experience in Regulatory Affairs, including preparation of submissions to the FDA/EU.
• A minimum of 3 years of experience in medical device
• Experience with Document Control Software (Grand Avenue preferred)

MARGINAL JOB FUNCTIONS:

• Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, and peers.
• Ability to manage competing priorities and projects of various sizes,
• Willingness to work with changing priorities (versatility, flexibility)
• Advanced knowledge of overall business environment, the orthopedic industry, and the marketplace; strong product knowledge.
• Must work precisely according to procedures, rules and regulations, has a passion for continuous improvement and quality.

PHYSICAL DEMANDS: While performing the duties of this job, the employee is regularly required to sit and talk and hear. The employee is frequently required to stand, walk; and use hands to handle, or feel objects, tools, or controls. The employee is occasionally required to reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIORNMENT: Associate will normally work in an office environment but may also be subject to high noise levels from machines and physical hazards from moving machine parts. The work environment characteristics described here are representative of those an employee may encounter while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.