Job Summary: 

The incumbent will be responsible for maintaining and improving SunTech's Quality Management System and ensuring that SunTech's products meet the requirements of the US FDA, MDD and other regulatory agencies as required. 

SunTech is a US FDA registered establishment and its QMS is registered to ISO13485 with Intertek/Semko in addition to being registered with Japan, China, Canada and Brazil. In addition to the efficient operations throughout the company SunTech's QMS is essential for SunTech to continue shipping around the world. 

This position will be responsible for working with all departments and facilities to create regulatory documentation for all stages of medical device development, maintaining existing regulatory files, submitting 510(k)s to the FDA and working closely with SunTech's China facility to ensure that quality and regulatory policies are aligned. 

This position is also responsible for overseeing proper utilization of ComplianceQuest, an eQMS, that is just being integrated into the organization on the Salesforce platform. 

Skills 

  • Leadership –Strong and effective leader and mentor of regulatory staff 
  • Process development/improvement - strong aptitude for creating, standardizing and improving 
  • Managing complexity - proven ability to organize complex registrations 
  • Problem solving - collaboration with team members to identify root causes and creatively solve problems 
  • Communication - excellent communication skills (presentation, written and verbal) 
  • Change agility - ability to effectively change course in dynamic projects with changing scope standards and Regulations - well-versed in the EU Medical Device Directive, ISO standards and 21 CFR 820 

Responsibilities include but are not limited to: 

  • Manage QA/RA team who oversee all aspects of SunTech's quality management systems, ensuring compliance with all ISO13485, FDA and other regulatory and governmental requirements as required. 
  • Manage all aspects of SunTech's worldwide regulatory affairs, ensuring compliance with all applicable CE, FDA, CFDA, ISO and other governmental approvals with respect to all SunTech products. 
  • Champion SunTech’s quality policy and mission of continual improvement. 
  • Continually assess, track and provide monthly updates to the CEO on key metrics relating to quality, regulatory and customer service functions. 

Page 2 of 2 

  • Perform internal and external audits of SunTech’s processes, procedures and key suppliers. 
  • In conjunction with other departments, assess suitable new suppliers and maintain regular supplier audits. 
  • Ensure compliance with all legal and other directives in so far as they relate to the sales of SunTech’s products worldwide. 
  • Review and approve SunTech's labeling and ensure that it complies with domestic and international standards. 
  • Provide customer support on regulatory issues; 
  • Manage technical aspects of quality issues and problems; 
  • Develop and maintains product technical construction files; 
  • Develops 510K submissions and obtains FDA approval; 
  • Support product registrations for many countries on a worldwide basis; 
  • Provide project leadership for needed updates to existing products caused by new/revised standards; 
  • Support worldwide regulatory compliance of SunTech products and/or services, including RoHS, REACH and Risk Management; 
  • Work closely with other departments, especially Engineering, to ensure new products are in compliance with published standards; 
  • Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.; 
  • Conduct training and/or communicate appropriate material to internal staff to aid in compliance; 
  • Assist in developing regulatory affairs internal policies and procedures, and provide compliance training; 
  • Other duties as assigned. 

Physical Requirements: 

  • Work is performed in a normal office environment; 
  • 0-15% travel; Must be able to travel to China 

Minimum Qualifications: 

Education - B.S. degree in Engineering is preferred 

Experience – 

  • 10+ years of prior Quality and Regulatory experience 
  • 5+ years of medical device, biomed or pharma experience 
  • 5+ years of management or supervisory experience 

Competencies: 

  • Extensive knowledge of medical device regulations and standards. (e.g. FDA, MDD, ISO 9001, ISO 13485, etc.); 
  • IEC60601-1 3rd addition; 
  • RoHS/REACH experience preferred; 
  • Product registration knowledge and experience on a worldwide basis; 
  • Excellent organizational and multi tasking skills; 
  • Ability to work under pressure with strict deadlines; 
  • Detail-oriented; 
  • Good presentation skills; 
  • Proficient with MS Office, including MS Word, Excel, PowerPoint and MS Project. 

Please email your resume and cover letter to This email address is being protected from spambots. You need JavaScript enabled to view it.

We use cookies
Cookies are small text files that are downloaded onto your device when accessing this website and may entail sharing of data with 3rd parties. SunTech's cookies can be categorized as Required (necessary for the website to function properly, such as providing secure log-in or remember your preferences), Analytical (collect statistical usage data for website optimization) and/or Targeted Advertising (track your activity to deliver marketing content tailored to your interests, within and beyond SunTech websites). Click “ACCEPT” to agree to our terms and allow cookies or click “DENY" to refuse. If you choose "DENY" you may still access portions of this site, however, some functionality will not work.