Quality and Regulatory Affairs
QualityAt ARaymond, we create cutting-edge fastening and assembly systems for the machines and products that keep the world moving.
Founded in Grenoble in 1865, and still headquartered in the city to this day, we’re a family-run business with a proud history of innovation – including the invention of the press stud.
Human values have driven our success for over 158 years, embodied by our servant-leadership model of management that empowers employees and puts their wellbeing first.
Today we employ more than 8,500 people in 25 countries worldwide. And we’re committed to leading in sustainability for the global fastening and assembly market.
Connect the parts that keep the world moving
Working in a clean, green and high-tech production environment, you’ll help build cutting-edge fastening and assembly systems for the everyday innovations we all rely on.
Role and responsibilities
- 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
Education and experience
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