Imricor Medical Systems Inc
Senior Regulatory Specialist
Imricor Medical Systems Inc, Burnsville, Minnesota, United States, 55337
Basic Function
The Senior Regulatory Specialist is responsible for planning, managing, and implementing regulatory submissions to the EU notified body, the US FDA, and other country specific regulatory bodies. This position ensures continued compliance with regulatory agency approvals including change impact reviews. This position also is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.
Responsibilities
Develops domestic and international strategies for regulatory approval of company products.
Coordinates, compiles, and submits U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country specific product registrations.
Develops and maintains positive relationships with regulatory body reviewers through oral and written communications regarding clarification and follow-up of submissions under review.
Reviews product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings.
Represents RA on cross functional product development, manufacturing, and clinical support teams and provide regulatory leadership and feedback throughout the product development cycle. Provides recommendations for how to overcome regulatory barriers.
Provides technical reviews of supporting documentation for inclusion in regulatory filings.
Supports Medical Device Reporting (MDRs) and Medical Device Vigilance Reporting.
Represents RA on other cross functional projects which may include process changes and continuous improvement efforts.
Meets defined goals and objectives through own initiatives, activities, and available resources with minimal supervision.
Performs other related duties and responsibilities, as assigned.
Qualifications
Bachelor of Science in a scientific discipline or equivalent education/ training.
5+ years’ Regulatory and/or Compliance related experience in a regulated industry.
Previous experience with US and EU medical device regulatory requirements including Quality Systems and clinical investigations standards.
EU MDR transition experience preferred.
Australian regulations experience preferred.
Experience with preparation, submission, and approval for medical devices is required.
Strong communication skills, both verbal and written.
Strong analytical and problem-solving skills, as well as a good background in the medical device development process.
Demonstrated ability to effectively manage multiple projects and priorities.
Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat.
Working Conditions
Light work, exerting up to 20 lbs. of force or less.
Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
Requires typing, talking and hearing.
The statements above reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
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The Senior Regulatory Specialist is responsible for planning, managing, and implementing regulatory submissions to the EU notified body, the US FDA, and other country specific regulatory bodies. This position ensures continued compliance with regulatory agency approvals including change impact reviews. This position also is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.
Responsibilities
Develops domestic and international strategies for regulatory approval of company products.
Coordinates, compiles, and submits U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country specific product registrations.
Develops and maintains positive relationships with regulatory body reviewers through oral and written communications regarding clarification and follow-up of submissions under review.
Reviews product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings.
Represents RA on cross functional product development, manufacturing, and clinical support teams and provide regulatory leadership and feedback throughout the product development cycle. Provides recommendations for how to overcome regulatory barriers.
Provides technical reviews of supporting documentation for inclusion in regulatory filings.
Supports Medical Device Reporting (MDRs) and Medical Device Vigilance Reporting.
Represents RA on other cross functional projects which may include process changes and continuous improvement efforts.
Meets defined goals and objectives through own initiatives, activities, and available resources with minimal supervision.
Performs other related duties and responsibilities, as assigned.
Qualifications
Bachelor of Science in a scientific discipline or equivalent education/ training.
5+ years’ Regulatory and/or Compliance related experience in a regulated industry.
Previous experience with US and EU medical device regulatory requirements including Quality Systems and clinical investigations standards.
EU MDR transition experience preferred.
Australian regulations experience preferred.
Experience with preparation, submission, and approval for medical devices is required.
Strong communication skills, both verbal and written.
Strong analytical and problem-solving skills, as well as a good background in the medical device development process.
Demonstrated ability to effectively manage multiple projects and priorities.
Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat.
Working Conditions
Light work, exerting up to 20 lbs. of force or less.
Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
Requires typing, talking and hearing.
The statements above reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
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