ARaymondは、世界を動かす機械や製品のための、最先端のファスニングシステムとアセンブリシステムを生産しています。
1865年にグルノーブルで創業し、現在もこの土地に本社を置く当社は、家族経営の企業です。プレススタッドの発明をはじめ、さまざまな技術革新を生み出してきた歴史を誇りとしています。
158年以上にわたって当社の業績を支えてきたものは、社員に力を与え、社員の幸福を第一に考える、サーバント・リーダーシップに基づく経営モデルです。
当社では現在、世界25か国以上で8500人以上の社員が働いています。ARaymondはこれからも、世界のファスニング&アセンブリ市場の持続可能性を牽引すべく取り組んでまいります。
世の中を動かす製品を
人々が日常的に利用しているモノを支える当社のファスニング&アッセンブリシステム。最先端の技術が整ったクリーンな環境で、製造業務を行うことができます。
職務
- Write, analyze, and edit technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada, Europe and India.
- Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
- Maintain regulatory files.
- Maintain and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, NRTL certifications etc.
- Maintain Compliance with respect to Combination products and 21CFR Part 820
- Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports.
- Support approval in other regions as required.
- Assist in preparing response to regulatory authorities questions within assigned timelines.
- Stay abreast of regulatory procedures and changes in regulatory climate.
- Assess device related incidents/complaints for medical device reporting requirements.
- Compile and submit reportable events to relevant regulatory authorities in timely manner.
- Handle recalls and field actions, if required.
- Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
- Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
- Assist in preparing clinical trial site ethics review board applications for investigational device trials. Prepare interim or final reports for trial site ethics boards as required
- Other duties as assigned.
Key Attributes
- Self & Team Management
- Minimum of 2 years regulatory or equivalent experience within a device or pharmaceutical company, CRO, or similar organization
- Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills
- Excellent written and Verbal communication skills with the ability to listen, articulate and advocate
- Proactive, high performance, result oriented and manage projects with ethical integrity
- Technical system skills (e.g. MS office applications, databases, efficient online research)
- Manage multiple projects and deadlines
- Ability to identify compliance risks and escalate when necessary
Demonstrate both creative and critical thinking skill
ISO 27K-
- Maintaining awareness and adherence about applicable information security policies and procedures
- Maintaining compliance with contractual requirements
- Ensuring information, they use or information under their custody is adequately protected as per ARaymond information security expectations.
- Reporting any noted suspicious behavior, vulnerability, and incidents to authority
学歴&職歴
Graduation/ Post Graduation in with Specialization in Pharma/ Engineering along with 15- 20 Years of experience
スキル
- Knowledge of 5S methodology
- Team-Working
- Environment, Health, and Safety Risk Management
- Customer Service Orientation
- Workplace Emergency Preparedness
- Decision Making
- Knowledge of EHS Standards and Procedures
- Communication Skills
- Knowledge of ergonomic working conditions
- Accountability and Ownership
- Root cause analysis
- Knowledge of Plastic Raw Material
Knowledge of Steel Raw Material