Regulatory Affairs Specialist, MDR - Intern

Company: Kerr
Location: Brea
Posted on: June 23, 2022

Job Description:

The Kerr Dental portfolio of brands and product solutions spans restoratives, endodontics, and rotary instruments, with a common purpose of enabling healthy, beautiful smiles while providing an exceptional customer experience globally. Kerr's 130+ year history of innovation began in 1891 in Detroit, Michigan and has since expanded on a global scale to ensure dental professionals receive the consumable products they trust most. Kerr's market-leading brands include OptiBond, SonicFill, Harmonize, MaxCem Elite, and many more. Learn more at www.kerrdental.comJob Description:

• The assembly of the CE Technical Files with direct oversight from the RA team
• Collaborates with other departments to gather documentation needed to compile CE Technical File.
• Provide regulatory support for Health Authority submissions including, but not limited to proofreading documentation.
• Tracks submissions and maintains electronic and paper regulatory correspondence and approvals (ex: EU and ROW).
• Organize and maintain files/folders/databases to support the integrity of RA documentation.
• Order documents, subscriptions, articles, standards and other items.
• Follows up on actions taken to resolve regulatory issues and ensure companywide compliance.
• Reviews regulatory publications to keep apprised of new regulatory developments.
• Performs special projects at the direction of the Regulatory Affairs Management.
• Responsible for assisting in regulatory review of product claims and literature.
• On-site officeJob Requirements:
  • Familiarity with EU MDR requirements for medical devices.
  • Adaptable to learn how to pull data and documentation from various databases and compile into CE Technical File.
  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.
  • Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
  • Proficient with Microsoft Office.
  • Must be detail-orientated and self-motivated.
  • Strong communication, problem solving, and motivational skills.
  • Demonstrated written and verbal communication skills.
  • Possess a high degree of accuracy and attention to detail.
  • Ability to work independently, as well as within the team.
  • Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
  • Ability to navigate through large Excel documents.
  • Competent with adding hyperlinks in Word.
  • Ability to perform repetitive copy/paste function in Word and .pdf documents.
  • Competent with adding bookmarks in .pdf files.
  • Ability to quickly learn new database navigation.
  • Bachelor's degree (B. A.) from four-year college or university.
  • 1-2 years related experience and/or training; or equivalent combination of education and experience.
  • While performing the duties of this Job, the employee is regularly required to sit. The employee is frequently required to walk. The employee is occasionally required to stand. The employee must occasionally lift and/or move up to 10 pounds.IND123Operating Company:KerrEnvista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.About EnvistaEnvista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including KaVo, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care.Envista separated from Danaher as an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.

Keywords: Kerr, Fullerton , Regulatory Affairs Specialist, MDR - Intern, Other , Brea, California