Regulatory Affairs Associate Specialist
Location: Corporate Office - Leesburg, VA
Requisition Number: req392
Responsible for assisting the team with regulatory filings as necessary to market K2M products globally. This is a mid-level position, providing training towards full competency in Regulatory Affairs (RA). This position requires an understanding of K2M products and their use as well as an understanding of the regulatory submissions process. May perform some or all of the below functions, depending upon their specific assigned focus.
Essential Duties and Responsibilities include the following:
• Supporting the preparation, submissions, filings, input requests and renewals for K2M products in global markets.
• Requesting Certificates of Free Sale when appropriate.
• Assisting with maintaining registration of product master files, electronic databases, logs and technical documentation
• Specific focus on timely reporting on adverse events, incidents, vigilance reports to global authorities, managing the reporting files according to global regulations.
• Ensure timely filing of follow-up / final reports for global authorities in regards to adverse events / incidents.
• Working directly with global distributors/representatives on adverse event/reporting activities
Knowledge, Skills, and Abilities required:
• Ability to interpret technical documents
• At least 1 year of MDR, vigilance reporting regulatory experience
• Strong decision making skills
• Strong written and communication skills
• Ability to work independently, plan, and prioritize with little supervision
• Medical Device experience with FDA Code of Federal Regulations (CFR) and GMP requirements, preferred.
• Familiarity with ISO13485 preferred
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed here are representative of the knowledge,
skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Bachelor’s degree in a business, technical or science-related field
• One year experience within a medical device manufacturing environment with direct quality system or regulatory working knowledge, preferred.
• Training in FDA and ISO Quality System regulations and standards preferred.
Ability to read, analyze, and interpret general business periodicals, professional journal, technical procedures and reports, and governmental regulations. Ability to write reports and business correspondence.
Ability to understand engineering test reports. Ability to read and understand engineering drawings.
Ability to define problems, collect data, establish facts, and draw valid conclusions. The position requires the ability to apply common sense understanding to carry out
instructions furnished in written, oral, or diagram form. Good analytical skills are a plus.
Proficient in Microsoft Office suite, particularly Excel.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable
K2M is an Equal Opportunity Employer
accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly
required to use hands to finger, handle, or feel objects, tools, or controls. The employee frequently is required to stand, walk, sit, reach with hands and arms, and talk or hear. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.