Regulatory Affairs Specialist

Masimo

2 - 7 years

4 - 8 Lacs

bengaluru

Posted:-1 days ago| Platform:

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Skills Required

medical devices interpersonal skills iso 13485 quality systems agile life sciences computer proficiency gmp risk analysis ms office word

Work Mode

Work from Office

Job Type

Full Time

Job Description

Support the regulatory team managing international and domestic filings/registrations, including drafting and compiling of 510(k) Premarket Notifications, technical files, STED Documents and related submissions;
Coordinate with regional regulatory team members on product changes and regulatory notification / approval requirements;
Assist in communications with regional regulatory representatives to assist in filings and responses to inquiries from health authorities and notified bodies worldwide;
Assist in compiling and submitting product list on Certificate of Foreign Government and Free Sale Certificates;
Assist in maintaining product listings and establishment registrations with FDA;
Assist in maintaining regulatory databases and summary reports to support management efforts to track and trend filing and registration requirements worldwide;
Maintain up-to-date knowledge on international and domestic regulatory requirements;
Generate and maintain product compliance checklists;
Provide regulatory support to the OEM Deployment group;
Work with QA and Engineering in generating risk analysis, FMEA, and FTA reports;
Submit document change orders (DRO/agile) for approvals;
May represent RA department in project meetings and provide regulatory guidance;
Update RA responsible quality system procedures as required (SQP/SOP s);
Performs other duties or special projects as assigned;

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

A minimum of 2 years of work experience in a medical device Class II/ III environment;
Working knowledge of FDA or international regulations.
Computer Proficiency with MS Office (Word/Excel/Access/Outlook);
Excellent verbal and written communication skills;
Excellent prioritizing, organizational, and interpersonal skills;
Excellent documentation skills including record maintenance/ tracking and understand document traceability;
A detail-oriented individual with a can do attitude and ability to work in a team environment as well as individually with minimal supervision;
Ability to work in a fast-paced environment, with multiple tasks/projects;
Ability to work in a Project Team Environment;

Preferred Qualifications:

Experience in patient monitor systems, hospital-based products, software or electronic device products;
- Knowledge of regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submission;
- Experience with FDA/GMP requirements for medical device;
- Experience in Quality Systems per ISO 13485;
Experience with UL/ETL certification process;
- Experience interacting with regulatory bodies, such as the Notified Body;

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