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Job Description:
Location: Remote
Residency: UK, EU, EEA, Israel: Citizen/permanent resident required
Hiring Company: Oriel STAT A MATRIX (
Website
)
If you are an expert in medical device quality and regulatory affairs, looking for a long term contract with plenty of opportunity to grow your medical device RA/QA skills and experience, this role may be for you.
Founded in 1968, Oriel STAT A MATRIX is now a business unit of ELIQUENT Life Sciences, a leading global organization providing consulting and training services to the Regulatory Affairs and Quality Assurance functions within the Life Science industry. We are proud of our focus on client outcomes: we achieve superior client results because we select from a pool of highly skilled, specialized, commercially minded Quality System and Regulatory Affairs employees and a set of Affiliate consultants with exceptional skills in specific areas. Together, our team can execute best-in-class advisory, audit, consulting, and training services in the medical device market. We are looking for individuals who possess a level of skills, attributes, and talents commensurate with our brand.
The growing environment for medical/in-vitro device quality and regulatory affairs support services means we are currently seeking to add key experts into our Life Science practices. We are looking for individuals who possess a level of skills and talents commensurate with our brand.
Job Overview
This is a key role and will provide direction to medical device clients, establishing and managing globally compliant quality systems in a number of regulatory environments and auditing to a wide range of standards. Focus will be on US FDA and 510(k) submissions.
Principal Responsibilities Handle product registrations to accomplish both US and international successes for a wide range of product types within medical devices and in vitro devices. Conduct establishment, management and remediation of quality management systems commensurate with the target risk of products - particularly under 21 CFR 201/211, 820, 700, MDSAP, EU-MDR and ISO13485. Lead on the creation and filing of all technical documentation, submission of 510(k)s for the FDA and equivalent filings for EU-MDR.
Job Qualifications/Experience Bachelor's degree in related field such as (Engineering, Science, Regulatory Affairs or other applicable degree). Masters degree preferred. Demonstrated experience with EU-MDR, CFR 21 Part 820, ISO 13485; ISO 14971; pre-market, production and post-market aspects of the work; 510(k), CAPA, Technical Files, CE Marking, De Novo 4 - 5 years experience in the medical device industry Experience working on multi-disciplinary teams with demonstrated evidence to drive change by influencing all levels of the organization Ability to work in the Hebrew language will be a plus
Travel
There is no regular travel associated with this contract. There may be occasional business trips within Europe or to Israel.
Required Skills: •21 CFR part 820 •Technical Files •ISO 14971 •CAPA •EU MDR •ISO 13485 •CE marking •510k
Salary Package: $ 100.00 - 100.00 (US Dollar) #J-18808-Ljbffr
Location: Remote
Residency: UK, EU, EEA, Israel: Citizen/permanent resident required
Hiring Company: Oriel STAT A MATRIX (
Website
)
If you are an expert in medical device quality and regulatory affairs, looking for a long term contract with plenty of opportunity to grow your medical device RA/QA skills and experience, this role may be for you.
Founded in 1968, Oriel STAT A MATRIX is now a business unit of ELIQUENT Life Sciences, a leading global organization providing consulting and training services to the Regulatory Affairs and Quality Assurance functions within the Life Science industry. We are proud of our focus on client outcomes: we achieve superior client results because we select from a pool of highly skilled, specialized, commercially minded Quality System and Regulatory Affairs employees and a set of Affiliate consultants with exceptional skills in specific areas. Together, our team can execute best-in-class advisory, audit, consulting, and training services in the medical device market. We are looking for individuals who possess a level of skills, attributes, and talents commensurate with our brand.
The growing environment for medical/in-vitro device quality and regulatory affairs support services means we are currently seeking to add key experts into our Life Science practices. We are looking for individuals who possess a level of skills and talents commensurate with our brand.
Job Overview
This is a key role and will provide direction to medical device clients, establishing and managing globally compliant quality systems in a number of regulatory environments and auditing to a wide range of standards. Focus will be on US FDA and 510(k) submissions.
Principal Responsibilities Handle product registrations to accomplish both US and international successes for a wide range of product types within medical devices and in vitro devices. Conduct establishment, management and remediation of quality management systems commensurate with the target risk of products - particularly under 21 CFR 201/211, 820, 700, MDSAP, EU-MDR and ISO13485. Lead on the creation and filing of all technical documentation, submission of 510(k)s for the FDA and equivalent filings for EU-MDR.
Job Qualifications/Experience Bachelor's degree in related field such as (Engineering, Science, Regulatory Affairs or other applicable degree). Masters degree preferred. Demonstrated experience with EU-MDR, CFR 21 Part 820, ISO 13485; ISO 14971; pre-market, production and post-market aspects of the work; 510(k), CAPA, Technical Files, CE Marking, De Novo 4 - 5 years experience in the medical device industry Experience working on multi-disciplinary teams with demonstrated evidence to drive change by influencing all levels of the organization Ability to work in the Hebrew language will be a plus
Travel
There is no regular travel associated with this contract. There may be occasional business trips within Europe or to Israel.
Required Skills: •21 CFR part 820 •Technical Files •ISO 14971 •CAPA •EU MDR •ISO 13485 •CE marking •510k
Salary Package: $ 100.00 - 100.00 (US Dollar) #J-18808-Ljbffr