Sr. Regulatory Affairs Associate - Austin, Texas United States - 33680


Job #: 33680
Title: Sr. Regulatory Affairs Associate
Job Location: Austin, Texas - United States
Employment Type:
Salary: $75,000.00 - $90,000.00 - US Dollars - Yearly
Other Compensation: 10% bonus, solid benefits plan
Employer Will Recruit From: Nationwide
Relocation Paid?: Yes


The company is growing, 2020 has been a great year for them. The company does a lot of promoting from within and offers excellent benefits


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 

University - Bachelor's Degree/3-4 Year Degree


Our recruiters are currently seeking to fill this position and hundreds like this in our network. If you are a match you'll be contacted with additional details.

We value your privacy and will never share your information with any employer without your consent.

Send your profile and resume to the recruiter who posted this job. You may include a cover letter to introduce yourself.

Cover Letter Text:

5,000 character limit