STAAR Surgical Manager of Regulatory Affairs Job in Monrovia, CA | Glassdoor

Manager of Regulatory Affairs

STAAR Surgical – Monrovia, CA

Job Description

MAIN JOB RESPONSIBILITIES

• Prepares and manages all aspects of all ongoing and new regulatory submissions, both U.S. (e.g., PMA, IDE, 510(k), PMA Annual Reports, etc.), and international (e.g., CE Technical Files, Design Dossiers, APAC, etc.). Provide regular status updates and activity reports.

• Plans and prepares complex regulatory documents for global registrations.

• Ensures effective coordination and implementation of regulatory activities in support of new product approval/registration and maintenance in all markets.

• Critically reviews complex reports, validations, etc. for scientific merit and regulatory appropriateness.

• Maintains professional relationships with functional areas outside regulatory.

• Acts as company liaison with FDA and other Regulatory Agencies.

• Monitor and ensure appropriate ongoing Company-wide regulatory compliance with applicable GMP/ISO/EN standards and other pertinent standards.

• Reviews proposed labeling and promotional material to ensure that the intended use and claims are supported for use and domestic and international regulations are met.

• Provides strategic direction and advice to project team regarding regulatory pathways and timelines for new and changed products/processes.

• Establishes, organizes and maintains regulatory records.

• Obtains and manages foreign registrations; partner with appropriate representatives to locally confirm and file foreign regulatory requirements. Ensures compliance with global regulations and regulatory agencies.

• Maintains familiarity with current medical literature and surgical techniques in the field of ophthalmology.

• Supports the development and implementation of regulatory strategies throughout the product life cycle including product development , labeling, promotional materials and regulatory evaluation of changes

• Performs additional duties as assigned.


EDUCATION & TRAINING

• B.A./B.S. degree required.

• Advanced degree preferred.

EXPERIENCE

• Minimum of 5 years of hands-on experience in Regulatory Affairs (US and OUS) in the medical device or pharmaceutical industry required.

• Experience in intraocular lens or vision care industry preferred.

• Must have extensive experience preparing all types of PMDA/FDA/ISO/CE submissions and documentation.

• Experience managing clinical studies preferred.

• Experience interacting with domestic and international healthcare professionals and company management required.

SKILLS

• Good negotiation skills.

• Experience in intraocular lens or vision care industry preferred.

• Ability to work well independently and with others.

• Excellent organizational skills and attention to detail.

• Ability to handle multiple projects simultaneously and maintain flexibility.

• In-depth knowledge of regulations.

• Critical thinking skills and ability to follow-through.

• Working knowledge of PC-based word processing, spreadsheet, and relational database software required.

• Excellent written and oral communication, and technical writing and editing skills.


EEO/AA M/F/V/D