Business Analyst - IT - Regulatory Compliance Role will primarily focus on the enablement of Regulatory, Quality and Compliance Systems. Responsible for interfacing with Quality and Regulatory affairs groups build process maps, gather requirements, and write specifications to enable or enhance CAPA, Non-Conformance, Complaints, Audit Management and other post market functions in Quality Management, ERP and PLM systems. This role will be heavily involved in working on Quality Management System like TrackWise and platform to host EUMDR capability. Role ensures compliance with evolving applicable Global Requirements and Regulations such as the MDSAP, EUMDR & UDI.
- Understand and interpret regulatory requirements, industry standards, and best practices for medical device companies
- Analyze business processes and identify areas for improvement to ensure compliance with regulatory and quality standards
- Work with cross-functional teams like ERP and PLM to design, develop, and implement solutions to meet regulatory and quality requirements
- Manage the implementation of new systems and processes, and ensure proper training and documentation is provided to all stakeholders
- Monitor and maintain compliance with regulatory and quality standards, and provide regular updates to senior management
- Serve as the subject matter expert for regulatory and quality systems, and provide guidance and support to other departments and teams
- Bachelor's degree in a related field, such as business, engineering, or science
- Minimum of 5 years' experience in a business systems analyst or related role, with a focus on regulatory and quality systems in a medical device or other regulated industry
- Strong understanding of regulatory requirements and industry standards for medical devices
- Knowledge of EU MDR guidelines.
- Implementation experience with IT systems like SAP and TrackWise
- Excellent analytical and problem-solving skills, with the ability to identify and implement solutions to complex problems.
- Experience of RFP and vendor selection process.
- Strong project management skills and experience leading cross-functional teams
- Excellent communication and presentation skills, with the ability to effectively communicate with all levels of the organization.
Horizontal facilitates valuable and productive conversations between you and potential employers. We can assist you in growing your career by partnering you with employers that offer challenging assignments. For those that join the team, we offer competitive compensation and benefits including medical, dental, vision, and retirement. Check out all we have to offer and how you can become part of the Horizontal Talent Team. The pay range for this role is $58 - $69 per hour. This is not a guarantee of compensation, as final offer amount may vary based on factors including but not limited to experience and geographic location.
Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.
In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact email@example.com.
All applicants applying must be legally authorized to work in the country of employment.
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