Regulatory Affairs Manager
Company: ViziRecruiter,LLC.
Location: Aliso Viejo
Posted on: May 20, 2023
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Job Description:
Industry: Medical Technology and Pharmaceutical Level: Full time
Compensation: Base Salary Range: $109,100 - $158,100 Overview
Position Summary The -Regulatory Affairs Manager, based in
Burlington, MA will be responsible for the preparation of
regulatory submissions (foreign and domestic). Will ensure
implementation and maintenance of regulatory filings in compliance
with applicable regulations and company internal SOPs. Compensation
Compensation for each successful candidate will be based on several
factors, which may include qualifications, experience, education,
talent availability, and local market conditions. Range listed is
not inclusive of additional compensation such as bonus, equity, or
additional benefits. Responsibilities Maintenance Maintain
regulatory records. Maintain updated Regulations and Standards
information. Maintain contacts with various regulatory agencies to
determine proper regulatory pathways and time-lines. Prepare
Prepare regulatory submissions to regulatory agencies including
periodic written reports. Management Interact with Regulatory
Agencies as directed by management. Teamwork Participate in company
training programs that maintain appropriate awareness and
compliance with ISO, MDR, MDSAP and CFR requirements. Compliance
Interact and coordinate with Clinical staff to facilitate clinical
studies regulatory compliance. Quality Assurance Interact and
coordinate with R/D staff to ensure compliance to applicable Design
Control requirements and ISO standards. Requirements Experience
Hands-on experience in preparing MDD/MDR Technical documentation
with knowledge of clinical evaluation requirements. Solid
experience in regulatory compliance, particularly for EU and MDSAP
countries. B.A/B.S plus minimum of 5 years of hands-on work
experience in Regulatory affairs in the Medical Device area.
Experience in Ophthalmology is a plus. Knowledge Familiarity with
Brexit and new Swiss regulations with some exposure to US
regulatory. Knowledge of the MDSAP and EU Quality System
requirements. Familiarity with ISO standards including
ISO13485,14971and IEC 60601. About UsFounded in 1998, Glaukos
Corporation is an ophthalmic medical technology and pharmaceutical
company focused on novel therapies for the treatment of glaucoma,
corneal disorders, and retinal diseases.Our company was the first
company to bring to market Micro-Invasive Glaucoma Surgery (MIGS),
the micro-invasive procedure which revolutionized the treatment and
management of glaucoma. In 2012, we launched our first MIGS
device-the iStent --in the United States, followed by our
next-generation iStent -inject - -device in September 2018 and
iStent -inject - -W in September 2020.In November 2019, Glaukos
acquired Avedro, maker of the first and only FDA-approved
cross-linking technology for progressive keratoconus. And we
continue to seek to leverage our platform technologies to build a
comprehensive and proprietary portfolio of micro-scale surgical and
pharmaceutical therapies for glaucoma, corneal health, and retinal
diseases. Legal Disclaimer: Glaukos Corporation is an Equal
Opportunity/Affirmative Action Employer. view full text
Keywords: ViziRecruiter,LLC., Aliso Viejo , Regulatory Affairs Manager, Executive , Aliso Viejo, California
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