Regulatory Affairs Manager

Company: ViziRecruiter,LLC.
Location: Aliso Viejo
Posted on: May 20, 2023

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