Senior Regulatory Affairs Specialist
July 12th, 2018
HLT, Inc. is a clinical-trial stage company founded in Minnesota in 2002. We manufacture a transcatheter heart valve system, consisting of a catheter-based delivery system and heart valve, to treat aortic valve disease. The procedure is performed by an interventional cardiologist / cardiac surgeon in a cardiac catheterization laboratory, and is expected to be both less invasive and less costly than an open heart valve replacement procedure. The company currently employs approximately 100 people in Maple Grove, Minnesota.
In 2010 HLT was acquired by The Bracco Group, an international company active in the healthcare sector through Bracco Imaging. The group employs more than 3,300 employees worldwide and has annual total consolidated revenues of more than $1 billion.
HLT seeks passionate and talented people who can start contributing from day one. We want innovators seeking to advance the state of the art to improve patient outcomes.
The HLT Senior Regulatory Affairs Specialist will engage in planning and execution of global regulatory activities necessary to support implementation of clinical trials and subsequent commercial distribution of HLT transcatheter aortic valve systems. This position will provide regulatory functional representation and review of documentation related to clinical trials, labeling, design and specification, and manufacturing processes, as applicable to area of responsibility and according to US and international regulations, standards, and guidance.
Primary Duties and Responsibilities:
- Exercise creativity/innovation with expectations of independent research and use of accepted regulatory practices in the execution of tasks
- Provide hands-on regulatory affairs support for new product investigation/marketing approvals for new and existing products, including development of regulatory requirements/strategies and preparation of submissions
- Perform regulatory submission/approval activities for complex HLT products
- Represent HLT in interactions with US and international regulators on submission reviews/approvals and ensure compliance with required regulations and established corporate standards
- Define worldwide regulatory requirements necessary for (clinical trial and commercial) regulatory approval of products
- Complete regulatory assessments and strategies as required to support assigned projects and provide direction to project teams to support new product development and product modifications as required
- Provide direction on application of external standards for assigned projects as required
- Execute product submission strategies as directed.
- Maintain all regulatory documentation to ensure availability for audits and preparation of submission packages
- Rigorous documentation for all phases of regulatory submissions, including priority setting, requirements research, documentation gathering, submission writing, approvals, renewals, and change orders
- Understand and communicate current and evolving regulatory submission requirements for clinical trial and commercial distribution of medical devices in the US, Canada, and Europe
Qualifications (Knowledge, Skills & Abilities):
- BS degree in Science or Engineering or a combination of education and experience providing equivalent knowledge
- Minimum of 5 years medical device industry experience
- Minimum of 3 plus years of experience in Regulatory Affairs, including FDA, Health Canada, and/or EU submissions/approvals
- Working knowledge and experience with EU, FDA, and Health Canada regulations and guidelines
- Through understanding of FDA and international submission requirements including how to comply with standards and regulations
- Strong technical writing skills
- Ability to develop clear, concise, and timely oral and written reports, plus communicate tactfully with all levels of personnel
- Working knowledge of medical devices, procedures and terminology
- Proficiency with Microsoft Office
- 5 plus years working in Regulatory Affairs
- IDE submission experience
- Demonstrated ability in project management skills to plan, conduct and implement system assessments and robust submissions
- High level of planning and organizational skills
- Requires intense concentration to accurately assess compliance to applicable regulations for medical device manufacturers and comparing them to processes, policies, procedures and other quality related documentation, which may involve point-by-point comparisons
- The work is detail oriented, often with multiple priorities
- The environment is deadline sensitive. Frequent high-pressure situations
- Travel requirements are minimal. Travel about 1 time annually for 2-3 days duration trip
For further information about the position, please click here https://bit.ly/2mdDUMb