Regulatory Affairs Associate in Boerne, Texas at EKF DIAGNOSTICS INC

Ensures company and products are in compliance with applicable regulations and legislation. Assists in maintaining the appropriate establishment registrations as well as product registrations and/or licensing. Assist with the preparation, compilation, and review of regulatory submissions and related regulatory documents. Collaborate with manager, project teams, and functional area representatives to implement sound regulatory strategy.

Essential Functions, included but not limited to:

• Assist in monitoring implementation of new regulatory / legal requirements (including environmental legislation) in the relevant countries.
• Maintain list of external standards.
• Assist Regulatory Affairs department in preparing and submitting regulatory submissions such as 510(k) notifications for the US market and other regulatory documents in support of specific country registrations requirements.
• Work in partnership with other departments (i.e., engineering, quality, manufacturing, sales, marketing, etc.) as necessary to support regulatory submissions and regulatory compliance.
• Provide assistance with product vigilance/medical device adverse event reporting activities to include Medical Device Reporting (MDR) for the United States, and adverse reporting to Canadian authorities, etc.
• Assist in preparation and coordination of issuing Technical Bulletins or Advisories.
• Create and/or review product information in relation to Instructions for Use (IFUs), labeling, and sales and marketing literature.
• Create and/or revise Standard Operating Procedures, Work Instructions, etc. as directed.
• Assist with Regulatory Inquiries (internally and externally).
• Assist in preparation and maintenance of country specific technical documentation (US, EU, etc.).
• Assign and maintain Unique Device Identifiers (UDI) and database.
• Participate and assist in audits conducted by regulatory agencies, registrars, certifying bodies, and customers to include end-users, distributors, and other OEM customers, as applicable.
• Verify product marketing authorization (by country) and support release of product in system for distribution/sale within the authorized country.
• Support with the creation and/or completion of Safety Data Sheets (SDSs), Toxic Substances Control Act (TSCA), etc., upon request.
• Support compliance with Environmental, Social and Governance (ESG) Requirements.
• Adhere to current Good Manufacturing Practices (cGMP).
• Comply with Company policies, Quality Management System (QMS) and Standard Operation Procedure (SOPs), etc

Required Qualifications:

• High School Diploma or its equivalent.
• Legally authorized to work in the United States.
• Two (2) years proven quality and/or regulatory experience, within the medical device, In vitro diagnostics, biotechnology and/or pharmaceutical industries.
• Knowledge of ISO 9001, ISO 13485, and the Quality System Regulation (21 CFR Part 820).

Preferred Qualifications:

• Bachelor's degree (B.A./B.S.) from an accredited college or university in a science related field.
• 4 years quality and/or regulatory experience in relation to medical device or In vitro diagnostics devices.
• Knowledgeable with ERP systems such as ProAlpha, Oracle, SAP and AS400.
• Experience with regulatory submissions to FDA, EU Notified Bodies, etc.
• 1 year design and/or manufacturing experience.
• Qualified Auditor experience.

Basic Skills and Abilities:

• Detail oriented with a high level of accuracy, efficiency, and accountability.
• Good computer skills including Microsoft Word, Excel, Outlook.
• Excellent organizational skills to meet goals and set priorities.
• Proven ability to handle multiple projects and meet deadlines; work in a fast-paced environment.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Initiative to offer new innovative ideas and improve processes.
• Ability to work independently and as a member of various teams and committees.
• Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.