Vacancy expired!
- Preparation of US and International submissions, preparing and reviewing documentation to ensure compliance with internal and external quality and regulatory requirements
- Help with development of regulatory strategies for product submissions
- Write, review, and assess test protocols and reports
- Coordinate, write and review regulatory assessments
- Assist clients in identifying required pre-clinical testing
- Perform literature reviews
- Identify and interpret Standards and Guidance Documents applicable to medical devices
- Ensure relevant ISO and FDA Export requirements are met, as required
- Participate in assigned project development activities to ensure compliance with regulatory requirements
- Review and advise project team representatives on labels, labeling, protocols, reports and proposed product changes
- Work collaboratively with cross functional groups to develop project/regulatory solutions.
- Bachelor’s Degree in Science, Engineering, Healthcare, or related field
- Minimum of 5 years of medical device regulatory experience with current knowledge of medical device and/or biologics regulations.
- Familiarity with ISO 13485, US FDA QSRs, CE Marking, MDR,
- Experience in participating in regulatory audits/internal audits and inspections as appropriate
- Ability to professionally interact directly with government entities (e.g. FDA, notified bodies, etc.) on regulatory filings
- Ability to assess regulatory impact of design and/or manufacturing changes
- Knowledge of quality control processes and statistical techniques
- Demonstrated understanding of various types of mechanisms, materials, proper tolerance, drafting standards, and GD&T.
- Demonstrated competence in technical writing: protocols, testing results, procedures, statue and special reports
- Human factor requirements: Conduct of Human Factors Evaluations (HFE) for new or revisions to devices per US FDA Applying Human Factors and Usability Engineering to Medical Devices (2016), AAMI/ANSI HE75, IEC 62366
- Strong analytical and problem-solving skills; strong attention to detail
- Ability to read, analyze and interpret complex data and review technical documents
- Excellent verbal and written communication skills
- Strong interpersonal skills and the ability to work with cross-functional teams
- Project management experience preferred.
- ID: #23462135
- State: New Jersey Moonachie 07074 Moonachie USA
- City: Moonachie
- Salary: Depends on Experience
- Job type: Permanent
- Showed: 2021-11-25
- Deadline: 2022-01-23
- Category: Et cetera