Website Berman Larson Kane
Best Staffing Options since 1980
Regulatory Affairs Specialist
Location: Boston Andover MA. Area
Our Client is currently seeking an experienced Regulatory Affairs Specialist to work with cross functional teams within the Value Segments Solutions (VSS) business. These teams are located in several sites / time zones and include: Design, Manufacturing, Marketing, learning products and service/support personnel.
Product types will primarily be patient monitors and central stations. The VSS business is also responsible for diagnostic cardiology products.
- Bachelors Degree in Engineering, Clinical Sciences, Physical Science, Regulatory Affairs or related `discipline.
- At least 8 years of experience in medical device registrations and submittals.
- At least 2 years of experience handling active Medical Device submissions.
- Experience working with multi-site cross functional development teams.
- Demonstrated knowledge with US FDA 510(k) submittals, EU Technical file preparation and maintenance, working knowledge of China regulatory submittals, challenges and time lines.
- Previous experience for hosting audits and following up on audit findings.
- Willingness to participate in off hours meetings with the teams that are co’-located in China, United States and in some cases Brazil.
The following are positive attributes that are not considered as musts but will be considered in selecting a person for the job.
- Master’s degree in related field.
- RAPS Certification.
- Medical device experience outside of regulatory affairs.
- Job experience in a clinical site.
- Looking for ability to be a critical thinker that can assess situations and define multiple approaches.
- Ability to simplify complex issues and communicate requirements clearly both verbally as well as in writing.
- Experience with products sold by the VSS business: Patient Monitors and Diagnostic Cardiology Products ( Cardiographs, Holter Recorders, Holter Analysis SW, ECG Management Systems and Stress ECG Systems).
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