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SENIOR REGULATORY AFFAIRS ASSOCIATE

AUSTIN, TX
The Senior Regulatory Affairs Associate will be responsible for 
 
  • The responsibilities relating to both pre and post market compliance with US and international medical device regulations
  • Assisting with activities that support rapid entry into new markets upon development of new products and to maintain existing products
  • Developing 510k, Pre-Submission and IDE submissions, and ensures timely regulatory filings and documentation processes including technical files. 
 
Key Responsibilities & Duties: 
 
  • Prepare 510(k)s, letters/justifications to file, Investigational Device Exemption (IDE), Pre-Market Approval (PMA) Applications, PMA supplements and annual reports for both IDE and PMA as needed for Class I, II and III medical devices.
  • Prepares and assists in review and submission of regulatory submissions, product registrations and technical dossiers to Notified Bodies and Health Canada.
  • Prepare appropriate documentation for product CE mark certification.
  • Maintain regulatory documentation, registrations and device listings for both domestic and outside the US (OUS). Maintain international regulatory submission technical files, registrations/licenses, device listings and design dossiers for CE marking, and those required for Canada and other international countries outside the US.
  • Interacts effectively with functional business units in order to facilitate documentation requirements for submissions, ensuring that departmental timelines are met. Communicate and coordinate regulatory activities with other departments.
  • Prepares and evaluates regulatory documents and company specific SOP's to maintain FDA QSR & ISO 13485 compliance.
  • Provide appropriate regulatory guidance to research and operations staff.
  • Review and provide input to device labeling and advertising materials for compliance with FDA submissions and applicable regulations.
  • Review of product and manufacturing changes and compliance with applicable regulations.
  • Review of protocols and reports to support regulatory submission and product changes.
  • Participates on interdepartmental teams where required, including design control, FMEA, design and process validation, and associated documentation including written regulatory assessments for inclusion into the Design History Files.
  • Participate in compliance activities that relate to the department and the company as a whole.
  • Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards and apply appropriate implementation strategies.
  • Write/revise departmental SOPs as required
  • May assist with training and mentoring other RA associates and staff
  • Other duties as assigned 
 
Education and Experience: 
 
  • Bachelor’s Degree, degree in scientific field such as Biochemistry, Medical Technology, Chemistry, Biology is preferred
  • 3 years of industry experience in Regulatory Affairs, preparing and filing submissions such as 510(k), Pre-Submissions, IDE and maintaining regulatory documentation, registrations and device listings, both domestic and international
  • 5 years of experience in a GMP and/or FDA regulated environment, medical device industry or equivalent. Experience with in vitro medical devices preferred.
  • Experience working independently in a fast-paced environment with rapidly changing priorities
  • Experience as a Technician/Scientist or related biological discipline considered an asset
  • Experience working independently in a fast-paced environment with rapidly changing priorities 
 
Training, Skills and Certifications/Licenses: 
 
  • RA and/or CRA certification a plus
  • Working knowledge of FDA submissions requirements and terminologies (Pre-Submission, IDEs, 510k and PMA
  • Excellent organizational and project management skills with strong attention to detail.
  • Independent and self-directed individual
  • Successful experience working with cross-functional teams.
  • Effective written and verbal communication and technical writing skills
  • Strong skills and knowledge of corporate software tools -- Microsoft Office Suite including Word, Excel, Power Point 
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
"Bringing Talent to the Marketplace"

KP Recruiting Group is a well established and very respected recruiting firm.  We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients.  We are very experienced in many industries and have a wide range of clients.  We will serve as your advocate during your career search!  Let us do the work for you!  There is never a fee for our services!



 
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