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



JOB DESCRIPTION

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

WHY IS THIS A GREAT OPPORTUNITY?


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

JOB DESCRIPTION

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 

QUALIFICATIONS

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 

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

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