Document Control Specialist
Company: Aerotek
Location: West Sacramento
Posted on: February 23, 2021
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Job Description:
Hiring a Document Control Specialist for a remote opportunity
asap for a great scientific company in West Sacramento, CA!Needs to
have ISO 13485experience!Description:Position SummaryThis candidate
will assist in the proper labeling of the products produced at the
company's manufacturing facilities. The ideal candidate should have
knowledge in regulations related to cGMP and device GMP as well as
the regulations in other jurisdictions like Europe, Asia and
Australia. This candidate will participate in audits as needed and
support filings that the company will perform. The Regulatory
Affairs Specialist/Manager will work closely with the operations
team, directly report to the CEO and indirectly report to the
COO.Reporting RelationshipsDirect Supervisor: CEOIndirect
Supervisor: COOKey ResponsibilitiesConfirm compliance for marketed
products based on labeling claims with respect to all regions that
the products will be soldAssist in audits as neededPrepare and
submit filings for the different regulatory organizationsWork with
Operations to assemble quality and compliance dossiers for the
various productsWork with Operations to perform gap assessments for
customers related to their productsPrepare filings for different
jurisdictions Required Skills/AbilitiesUnderstanding of 21CFR600,
820 and ISO13485 regulationsExperience in regulatory filings with
FDA and other major regulatory agenciesGood written and verbal
communication skillsHave had direct communication with regulatory
agenciesPersonal AttributesDisplays understanding of and promotes
company and customer objectivesReadily adapts to changing job
dutiesWorks well in a team environmentDetail orientedResponds
quickly to assignmentsSkills:Iso 13485, Regulatory affairs, Medical
device, Fda, Labelling, Compliance, 21CFR600, 21CFR820, type one
medical device, 510KTop Skills Details:510K projects, regulatory
affairs, ISO13485, FDA, 21CFR820, regulatory compliance, GMP,
medical deviceAdditional Skills & Qualifications:Required
Skills/AbilitiesUnderstanding of 21CFR600, 820 and ISO13485
regulationsExperience in regulatory filings with FDA and other
major regulatory agenciesGood written and verbal communication
skillsHave had direct communication with regulatory
agenciesExperience Level:Intermediate Level About Aerotek:We know
that a company's success starts with its employees. We also know
that an individual's success starts with the right career
opportunity. As a Best of Staffing Client and Talent leader,
Aerotek's people-focused approach yields competitive advantage for
our clients and rewarding careers for our contract employees. Since
1983, Aerotek has grown to become a leader in recruiting and
staffing services. With more than 250 non-franchised offices,
Aerotek's 8,000 internal employees serve more than 300,000 contract
employees and 18,000 clients every year. Aerotek is an Allegis
Group company, the global leader in talent solutions. Learn more at
Aerotek.com.The company is an equal opportunity employer and will
consider all applications without regards to race, sex, age, color,
religion, national origin, veteran status, disability, sexual
orientation, gender identity, genetic information or any
characteristic protected by law.
Keywords: Aerotek, West Sacramento , Document Control Specialist, Other , West Sacramento, California
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