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Regulatory Affairs Specialist

1 month ago

Rancho Cucamonga, United States New World Medical, Inc. Full time

Description:
**JOB SUMMARY**:
The Regulatory Affairs Specialist is responsible for planning and executing global regulatory strategies necessary to obtain and maintain regulatory approvals for new and modified medical devices in International and US regions. The RAS translates regulatory requirements into project/product requirements, prepares regulatory submissions, and negotiates their approval with regulatory agencies as required. Primary responsibilities include; preparing, International and US regulatory submissions; prepare Technical File, providing documentation for international submissions; evaluating proposed product changes for regulatory impact, all while ensuring timely and high-quality execution of assigned regulatory deliverables.

**ESSENTIAL** **JOB** **DUTIES** **AND**

**RESPONSIBILITIES**:

- Help with development of regulatory strategies for product submissions in US and International market.
- Team with business unit to provide regulatory support for new products and changes to existing products. Work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
- Prepare FDA submission and CE Mark Technical Files for product changes and/or new products as required to ensure timely approvals for global market and relevant FDA and ISO requirements are met, as required.
- Review Change Orders and assess regulatory & labeling impact of product changes on US and International regulatory strategy and submissions.
- Preparation and maintenance of annual renewals of Establishment Registrations, State Manufacturing licenses, Device Listing, and other pertinent domestic and international licensing.
- Collaborate with R&D, Clinical, Quality, Manufacturing and Marketing and provide regulatory support when needed.
- Review complex reports, validations, etc. for scientific merit and regulatory appropriateness.
- Determination of regulatory submission requirements according to domestic and international regulations related to changes/new products/claims.
- Maintain/Index/Organize Regulatory library.
- Maintain technical knowledge of devices in area of responsibility.
- Maintain up-to-date on global regulatory requirements and assist in keeping company informed of regulatory requirements.
- Review/Prepare Standard Operating Procedures (SOPs) as needed.
- Perform additional duties as assigned.

**Requirements**:
**KNOWLEDGE,** **SKILLS** **AND ABILITIES**:

- Thorough understanding of FDA and international regulations.
- Strong working knowledge of medical devices regulations and terminologies.
- Excellent written and oral communication, and technical writing and editing skills.
- Ability to write clear, understandable technical documentation.
- Skilled at analyzing and summarizing data.
- Proficient with Microsoft Office.
- Ability to manage and prioritize multiple projects.
- Ability to follow written and verbal directions with a high level of accuracy.
- Ability to work independently with mínimal supervision.
- Extreme attention to detail.
- Ability to work in a team setting.
- Ability to effectively manage multiple projects and priorities.
- Effective interpersonal skills.

**EDUCATION** **AND** **EXPERIENCE**:

- Minimum Bachelor’s degree in a scientific related field or equivalent combination of education/experience. Advanced degree preferred.
- Minimum 2 to 4 years related experience, or equivalent combination of education and experience, required.
- Knowledge of Medical Device Quality Systems (21 CFR 820, ISO 13485)
- RAC Certification, preferred.
- International medical device regulatory submission/approval experience including EU, Japan and China, preferred.

**PHYSICAL**

**REQUIREMENTS**:

- Must be able to remain in a stationary position at least 50% of the time.
- Must be able to operate a computer and other office productivity machinery, such as a computer printer, computer keyboard, calculator, etc.
- Ability to listen and speak with employees and external partners, stakeholders, etc. Must be able to exchange accurate information in these situations.
- Occasionally lift up to 25 pounds. This may be performed with reasonable accommodation.
- View and type on computer screens for long periods of time.

This description reflects management’s assignment of essential functions, it does not proscribe or restrict the tasks that may be assigned.

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