Astrix Technology Group
Regulatory Affairs & Design Assurance Associate
|Post Date:||Apr 21, 2017||Type:||Full-Time|
|Start Date:||4/21/2017||Salary:|| |
- BS in Biological Science, Microbiology, Chemistry or equivalent.
- Proven knowledge of FDA and ISO regulated environment (Medical Devices, Pharmaceuticals, In Vitro Diagnostic Medical Devices strongly preferred).
- Minimum of six years experience in FDA/ISO regulated industry; Quality Assurance, Quality Systems, Design Control, Regulatory Affairs preferred.
- A minimum of three years of direct Regulatory Affairs experience is required, including preparation of Pre-IDEs, 510(k) applications, EU Technical Files, Canadian Class II and III licenses, STED documentation, et cetera.
- Experience with design, development and clearance of Medical Device Equipment preferred.
- Professional certifications such as CQA, CQE or CQM/OE preferred.
Skills, Specialized Knowledge and Abilities:
- Demonstrated strong leadership, project management and organizational skills.
- Highly motivated, detail oriented, must have a constant awareness of Customer Requirements and must demonstrate an ability to make fact-driven decisions; maintain accurate and concise records, uphold regulatory and quality system requirements including 21 CFR 820, ISO13485, 98/79 EC, and SOR/98-282.
- Demonstrated working knowledge of US FDA Quality System Regulations and ISO Quality Management System Standard for Medical Devices.
- Must be organized with strong attention to detail and able to prioritize and balance workloads and meet strict critical deadlines along with performing under pressure in a fast-paced environment.
- Readily adapts to changing priorities, effectively manages own time, sets priorities to ensure tasks, multiple projects are prioritized and completed on time.
- Must possess exceptional communication (written and verbal) skills, interpersonal skills, problem solving and ability to interact effectively with all levels of the organization both internally and externally.
- Ability to speak in large groups and actively engage participants.
- Strong background utilizing MS Office applications (Word, Excel, PowerPoint, Outlook) .
- Ability to read, understand and follow all company SOPs and guidelines.
- Ability to maintain regular attendance and punctuality requirements. May be required to work additional hours outside of the normal work shift to ensure departmental goals are met (evenings and weekends).
- Certifications- ASQ, RAC preferred
Requirements (Physical, Mental, Environmental Demands):
- Ability to walk up and down several flights of stairs throughout the work day in a multi-location facility
- Must be able to wear personal protective equipment (latex or nitrile gloves, safety glasses/face shields, lab coat, etc.).
- Must be able to adhere to applicable bio-safety practices when on the manufacturing floor.
- Ability to work on a PC including repetitive use of a keyboard and mouse for long periods throughout the course of the work day.
- Ability to sit and stand for long periods of time, stoop, reach, bend throughout the course of the work day.
- Must be able to analyze, concentrate and solve complex issues routinely through the course of the work shift and remain focused in a fast paced open environment throughout the course of the work day.
- Must be able to travel by car/air to other MBI locations and/or supplier locations as needed.
This person will support new product introductions, design control activities and global regulatory applications.
The Regulatory Affairs and Design Assurance (RADA) professional will be responsible for supporting all aspects the company's Product Realization process, ensuring products are designed and manufactured in a manner consistent with applicable Regulatory Requirements. The RADA Associate will be responsible for ensuring product compliance throughout all stages of the product lifecycle-research, development, transfer, validation/verification, labeling, regulatory application and maintenance. The RADA Associate will work with cross-functional teams to ensure that regulatory guidance is provided in support of business objectives.
- Provides Quality and Regulatory support to Design Control activities, including research and development, design transfer, clinical trials, validation and verification for new product introductions and existing product modifications. Serves as Quality Assurance/Regulatory Affairs Project Team Representative.
- Prepares product regulatory submissions in support of world-wide commercialization and business objectives.
- Evaluates technical protocols and data in support of Clinical Trials, Validation, Verification and product manufacturing.
- Directs activities associated with adverse events, medical device reportable events and product recall activities.
- Evaluates regulatory impact of changes associated with product design change and routine change control.
- Drafts and reviews product labeling, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
- Provides regulatory input to product lifecycle planning.
- Monitors product lifecycle and compiles information associated with changes as directed.
- Compiles new product technical information and feature summaries in support of international market expansion.
- Provides expertise to Marketing and Sales personnel to ensure content of collateral and promotional materials is fully supported and compliant with applicable regulations.
- Manages and completes long-term projects supporting the business and quality objectives of the organization.
- Assist in management of third party and internal Quality Audit programs; perform supplier audit and verification activities as directed.
- Other duties as assigned.
Astrix Technology Group
Name: Emily Holifield
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