Medical Devices- Associate Regulatory Affair
2 weeks ago
Assist RAM in managing the provision of certification services related to regulatory requirements in the medical device sector. Support the DQS RAM in respect to the MDSAP and ISO 13485 clients seeking certification via DQS MED Notified Body in Germany. Support the DQS Inc. US Medical Sales team in sales verification reviews prior to the New Business creation. Help to strengthen the US Medical Team as we continue to add new clients working alongside RAM.
ESSENTIAL FUNCTIONS:
- Basic knowledge in certification of management systems.
- Basic knowledge of the applicable standards, guidelines and specifications for accreditation including the requirements for notification and for designation and the specification documents applicable in this context and relevant specifications (e.g. IMDRF, MDSAP documents)
- Understanding/Growth potential in project management.
- Basic Knowledge of the relevant standards for certification of medical devices and management systems for manufacturer of medical products (EN ISO 13485,
MDSAP) as well as the role for the certification authority.
- Basic knowledge base of technologies in the field of products as well as design and manufacturing of products
- Demonstration of neutrality, impartiality, and freedom from personal interest during the review and evaluation of assessment reports
- Responsible for New MDSAP/ISO 13485 Clients signing up and working towards managing current clients.
- Supporting Sales on review of New Business and completeness of Initial Sales Paperwork.
- Managing the requests on Transfers to other Notified Bodies from Sales
- Audit Reports
- Complaint Data requests
- Train and Learn requirements of DQS Med.
- Assist in maintaining and improving current processes/procedures.
- Support assigning training auditors to audits.
- Perform other duties as assigned.
EXPERIENCE/EDUCATION REQUIRED:
- HS Diploma min., Bachelors preferred but not required.
- Computer Skills: Microsoft Office - Excel, Word, PowerPoint, Outlook, Teams etc.
- Must be flexible and be willing to work beyond standard work hours as needed.
- Ability to work productively in teams.
- Strong analytical skills.
- Strong interpersonal and communication skills.
- Ability to travel domestically primarily and internationally occasionally.
DQS Inc. is an Equal Opportunity Employer. Minorities/Women/Veterans/Disabled
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