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
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