Quality and Regulatory Affairs
QualitàNoi di ARaymond creiamo sistemi di fissaggio e assemblaggio all'avanguardia per macchine e prodotti che fanno muovere il mondo.
Fondata a Grenoble nel 1865, dove ancora oggi ha la sua sede, ARaymond è un'azienda a conduzione familiare con una storia orgogliosa di innovazione, compresa l'invenzione del bottone a pressione.
I valori umani hanno guidato il nostro successo per oltre 158 anni, incarnati dal nostro modello di gestione fondato sulla servant-leadership, che dà potere ai dipendenti e mette il loro benessere al primo posto.
Oggi impieghiamo più di 8.500 persone in 25 paesi in tutto il mondo. E siamo impegnati a essere leader nella sostenibilità per il mercato globale del fissaggio e dell'assemblaggio.
Connetti le parti che fanno muovere il mondo
Lavorando in un ambiente di produzione pulito, ecologico e ad alta tecnologia, contribuirai a fabbricare sistemi di fissaggio e assemblaggio all'avanguardia per le innovazioni quotidiane su cui tutti facciamo affidamento.
Ruolo e responsabilità
- 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
Formazione ed esperienza
Graduation/ Post Graduation in with Specialization in Pharma/ Engineering along with 15- 20 Years of experience
Skills
- 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