- BS degree in relevant discipline (Mechanical or Biomedical science engineering) with years of experience in product design Regulatory requirement
- Certification such as RAC (Regulatory Affairs Certification) is often preferred
- Quality or Regulatory compliance experience
- Experience with product lifecycle management, premarket and post-market product line support.
- Strong understanding and wide application of technical or regulatory principles, theories, and concepts; general knowledge of other related disciplines
- Good exposure in Medical Device product development process.
- Shall work independently
- Review regulatory submissions for new products and product changes as required to ensure timely approval for clinical studies and product market release.
- Review significant regulatory strategies with leadership team, as necessary..
- Provide on-going support to core and project teams for regulatory issues and questions. Investigate, interpret and apply regulations and guidance appropriately for situations.
- Review business and product information to RA Leadership to enable development of strategies and requirements to communicate information to leadership team.
- Provide regulatory support for currently marketed products as necessary. This includes reviewing labeling, promotional materials, changes to existing devices and documentation. Prepare submissions and reports for regulatory agencies as required.
- Work with RA Leadership and other members of the RA team to help support discussions with FDA or other regulatory agencies, as needed.
- Significant changes will be reviewed with the RA Leadership.
- Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
- Interact frequently with different members of the organization and outside customers.
- Keeps current on global directives, harmonized standards and procedures and communicates changes that may affect cross functional areas.
- Review training, promotional and advertising pieces for assigned product lines.
- Provide training and support to other members of the organization.
- Support Quality Systems Projects as required.
- Adhere to all company policies, procedures, and business ethics codes.
- Duties may be modified or assigned at any time based on business need.
- Ability to provide solutions to a wide range of difficult problems.
- Solutions are imaginative, thorough, practical, and consistent with organizational objectives.
- Ability to analyze a wide range of information, including conflicting and ambiguous inputs and propose solutions.
- Strong organizational, time management and project management skills
- Strong knowledge of Microsoft Office
- Effective presentation and interpersonal skills
- Self-motivation
- Excellent verbal/written communication skills
- Strong attention to detail and accuracy
- Ability to communicate persuasively in a manner that supports approvals and other key company goals/objectives.
- Able to work effectively both independently and in a collaborative team environment
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Quality Specialist - Irvine, United States - HCLTech
Description
About us : HCLTech is a global technology company, home to more than 223,400 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2023 totaled $12.8 billion. To learn how we can supercharge progress for you, visit Website -
Minimum Qualifications
Preferred Qualifications
Competencies Required
Required Knowledge, Skills
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