Senior Regulatory Affairs Specialist

*5 – 8 hour shifts or 4 – 10 hour shifts

Please make sure all resumes submitted are up to date and include salary requirements

Work in Millstadt, IL in a climate controlled facility.

The Senior Regulatory Affairs Specialist is responsible for planning and executing regulatory activities necessary to obtain and maintain regulatory approvals within the US and internationally. This role will provide support for regulatory activities including technical writing to support regulatory submissions, product labeling and instructions for use creation. This role focuses on regulatory support for the US and Global markets, with a wide variety of regulatory tasks to allow you to make the most of your existing knowledge base while growing your RA skill set every day. In this role, you will have primary RA responsibility for multiple Class I and Class II products, working within a collaborative team environment that fosters professional development while focusing on meeting business objectives with excellence. From developing and authoring regulatory submissions to providing critical input on cross-functional project teams, this role is an excellent opportunity for the right regulatory professional to take their career to the next level.

ESSENTIAL FUNCTIONS:

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Help with development of US and International regulatory strategies for product submissions.
• Assist in keeping company informed of regulatory requirements in the US and International Regions
• Participate on Product Development teams, providing regulatory labeling strategy, timelines, and direction
• Support preparation of US and International submissions.
• In conjunction with the Quality department, ensure relevant ISO and FDA requirements are met, as required
• Review Change Orders and assess regulatory & labeling impact of product changes on US and/or International regulatory strategy and submissions per standard procedures
• Technical Writing: Authoring regulatory documentation including SOPs, product manuals, Instructions for Use (IFUs), process flows and work instructions.
• Review labeling, training, promotional and advertising material
• Comply with applicable FDA and international regulatory laws/standards and MAC Medical Policies.
• Other duties as assigned.

IDEAL CANDIDATES WILL HAVE:

Experience with reading prints, welding, use of measuring tools (tape measure, calipers). The QA Inspector would be responsible for in-process inspection/verification throughout the plant and will work with production personnel to ensure the required inspections are documented.

JOB QUALIFICATIONS

• Minimum of 4 years of medical device regulatory experience, or advanced degree with a minimum of 2 years medical device regulatory experience
• Experience with 510(k) submissions
• Knowledge of FDA requirements
• Knowledge of EU requirements
• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Product Labeling requirements and standards
• Technical Writing
• Systems Knowledge such as RA systems, management systems
• History of successful 510(k)/IDE/PMA device submissions and other worldwide submissions and clearances.

SKILLS

• Very high level of interpersonal skills to work effectively with others.
• Understanding / working knowledge of customer requirements globally
• Proven ability to quickly learn and understand complex topics
• Previous experience writing documentation and procedural materials for multiple audiences
• Superior written and verbal communication skills, with a keen eye for detail
• Experience working with engineering to improve user experience: design, IFUs, and help refine content and create visuals and diagrams for technical support content
• Customer focused team player, excellent communication skills and resolve problems while maintaining productive working relationships with partners.
• Must be able to plan, organize, and implement multiple concurrent tasks and projects.
• Strong computer skills, including Excel (pivot tables), Microsoft Office, SharePoint, Access database, knowledge and experience of a modern ERP system (Intuitive ERP preferred)

PHYSICAL JOB REQUIREMENTS

• Excellent verbal and written communication

MENTAL & VISUAL JOB REQUIREMENTS

• Clarity of vision at 20 inches or less.
• Clarity of vision at 20 feet or more.
• Ability to bring objects into sharp focus.
• Ability to learn and comprehend instructions and orientation to the job.
• Ability to concentrate attention on the task at hand for extended periods of time.

WORKPLACE ENVIRONMENTAL CONDITIONS

• Typical 85% office environment, 15% factory environment

SOFTWARE

• Microsoft Office: Outlook Email, Microsoft Excel, Microsoft Word, PowerPoint, Microsoft Access, Intuitive ERP Client
• Intuitive ERP
• Unipoint Quality Management Software

 

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