Job Description
· Perform assigned regulatory activities including submissions/responses to country authorities.
Daily Responsibilities - Job Description suppliers should use:
· Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files under review.
· Assist in strategy implementation and operations for regulatory affairs activities, including development of EU MDR Technical File submissions and responses to Notified Bodies.
· Assist in maintaining Regulatory records and files.
· Review product changes as assigned and assess required EU MDR submissions/notifications.
Educational Requirements:
· BA Degree required, preferably in a science, engineering or technology discipline.
· Work Experience Requirements: 3-5 years experiences in Medical Device Regulatory Affairs Top
Skills:
· Strong oral communication and interpersonal skills
· Proficient in technical writing
· Excellent organizational ability, capability to manage multiple, dynamic projects simultaneously.
· MS Office Suite including an Intermediate level with Excel using Pivot Tables, Creating Trackers in Excel and monitoring these/Conditional Formatting.
Company Description
Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
Collabera is a Global Digital Solutions Company providing Software Engineering Solutions for the world's most tech-forward organizations in the areas of Engineering, Cloud and Data/AI. With its roots serving the engineering needs of the world's most recognized businesses in Technology, Financial Services, Telecom and Healthcare, Collabera today operates across 60 locations in 11 countries, serves 30% of the Fortune 500, and has exceeded the industry growth rate by 3-4x for several years.
...Job Title: Court Reporter (Grand Jury Transcript) Location: Baton Rouge, LA Duties: Unless otherwise stated, Grand Jury testimony shall be typed in an original and delivered within the turnaround times as set forth below. All Grand Jury transcripts shall contain...
...Junior Graphic Designer Ridge, NY Why Join Us? At New York Cancer & Blood Specialists (NYCBS) , we foster an environment where passionate professionals thrive. Our 200+ oncologists, hematologists, and staff across 25 locations are united by a mission: redefining...
Job Description Job Description Job Title: MQ-9 Pilot Department: Unmanned Aviation Svcs Reports to: Dir, Unmanned Aviation Svcs Location: Yuma, Arizona Full/Part Time: Full-Time/Flex Remote work authorized: Yes- this position is 90 days on / 90...
...Allied Universal, North America's leading security and facility services company, provides... ...where appropriate; escort visitors and contractors, secure ingress and egress points,... ...years of law enforcement, military, or private armed security experience Minimum of...
...Job Description Job Description Position -Sr. Regulatory Affairs Manager Location - Sunnyvale, CA Full time Salary - $1... ...Benefits Bachelors degree in Science, Engineering, Math, a medical field, or an equivalent educational background with a focus on...