CMS Careers at a glance
Regulatory Affairs Specialist
SUMMARY: The Regulatory Affairs Specialist shall complete Regulatory Affairs and Quality Assurance projects and recurring responsibilities in furtherance of the creation, implementation, and maintenance of the Elekta Region North America (RNA) or Business Area Software Systems (BASS) Quality Systems.
LEVELING REQUIREMENTS: Level 2: Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action.
Level 3: Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Level 4: Works on complex problems where analysis of situations or data requires an inīˇdepth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criterion for obtaining results. Work leadership may be provided by assigning work and resolving problems.
Level 5: Works on extremely complex problems where analysis of situations or data requires an evaluation of intangible variance factors. Exercises independent judgment in developing methods, techniques, and evaluation criterion for obtaining results. Work leadership may be provided by assigning work and resolving problems.
ESSENTIAL DUTIES AND RESPONSIBILITIES
As directed by the Director of Regulatory Affairs, the RA Specialist shall identify, analyze, understand, and take appropriate steps to ensure that the organization complies with all regulatory requirements, while also ensuring that compliance efforts do not unduly interfere with the efficiency and effectiveness of the operational management systems.
The RA Specialist shall conduct exhaustive regulatory reviews, compliance gap analyses, implementation planning, and project management to ensure compliance with applicable regulatory requirements. Routine responsibilities include risk management, security and safety incident handling, incident reporting, premarket notifications, regulatory clearance submissions, and monitoring the international regulatory landscape for new enactments that may affect the organization. Other duties may be assigned.
QUALIFICATIONS:
- Organizational Management System Experience: Quality culture building, Project management, Team management, Interfunctional coordination, Employee training, Statistical analysis, Management reporting
- Quality System Experience: Technical writing, Procedure writing, Quality system structuring, Document control, naming, and version control, Corrective/preventive action, Internal quality auditing, Verification and validation, Change control and planning.
- Regulatory Experience: Medical device regulation, Application of external standards, Auditing to an external standard, External regulatory audits, Laws and regulations, Risk management.
- basic Administration Experience: Basic office software applications, Online research, Critical reading, Filing and labeling, Typing / data entry, Proofreading, grammar, and spelling, Report and record generation, Multi-project queueing and multitasking.
- Excellent written and verbal skills are required.
EDUCATION AND/OR EXPERIENCE
Bachelor's degree in a related field (Business Management, Quality Assurance, Law and Regulation, Technical Sciences, Engineering) and a minimum of three years related quality system /organizational or operational management /regulatory compliance /auditing experience. Medical device and software design control experience preferred. Certified Quality Auditor preferred.
Business Line Manager, TPS - Treatment Planning Software (TPS) portfolio
REPORTS TO: Director Business Line Management TPS
DESCRIPTION:
- Contribute to the TPS Business Plan to increase profitability of Elekta's Software business
- Contribute to the generation of the product roadmap
- Monitor the progress to the deployed product roadmap regularly to get the right mix of products and ensure Elekta meets market demands and the goals of the TPS Business Plan
- Provide support and guidance to Elekta Sales teams, informing management of current trends and issues
- Work closely with the Software Business Line Marketing team to deliver effective outbound messaging and promotions to enhance the Oncology product line's visibility and attractiveness in the Global market
- Exhibit leadership to positively influence the direction of the company while working with the regions and the relevant Business Areas
RESPONSIBILITIES
- Support the generation of the TPS Business Plan for designated product lines
- Analyse competitive products and offer guidance to Sales and Marketing for pre-sales, Market positioning, and product roadmap development
- Manage relationships with OEM for designated product lines
- Travel to exhibitions (e.g. AAPM, ASTRO, ASCO), local and regional meetings, conferences to represent Elekta
- Identify and explore product and marketing opportunities to increase growth potential of existing products worldwide and potential for new products: Product availability and costs, Competitive analysis, Historical and current market trend analysis
- Define customers and channels to reach them, conduct customer needs assessment
- Help develop and implement the company's positioning and pricing strategies to increase market share and overall profitability, in close coordination with selling division management
- Explore new ways of promoting new and existing products
- Take the lead in developing product claims and value propositions to promote existing products, and to discover/suggest changes which should be made to existing products to create a new product
- Prepare and promptly submit administrative and technical reports as requested by management.
- Ensure compliance with company procedures relating to the handling of complaints and complaint files
- Perform other related duties as assigned or requested
- Incorporates Elekta Values into all department functions and responsibilities
AUTHORITIES
- Guidelines for product pricing and COGS
- Positioning of products per region/business area
- Management of project priorities at TPS Program Steering Groups (PSG) to meet business objectives
RELEVANT KNOWLEDGE, SKILLS, COMPETENCIES:
- Degree level in a relevant discipline
- 5-10 years of Oncology specific business experience with at least 3 years of marketing/sales experience and at least 3 years of successful management experience
- Knowledge of all the company's markets, products, and services
- Ability to see long-term organizational mission and motivate others to see the same
- Resourcefulness to determine how to get there
- Team player on both departmental and management team levels
- Strong verbal and written communication skills/ability to make top management level presentations
- English language speaking, excellent communication and writing skills
- Ability to create documents and presentations in Microsoft Office applications
- Ability to communicate complex radiation treatment planning principles and processes to mixed audience including: Technologists, Medical Physicists, and Oncologists
- Understanding of clinical protocols for IMRT, 3D-Conformal, SRS, and SBRT desirable
Product Marketing Manager - Treatment Planning Software (TPS) portfolio
SUMMARY:
Working with all regions and related operations, the Product Marketing Manager (TPS) develops and executes marketing strategies for software systems on a global basis by creating launch, segmentation, promotional and general marketing plans intended to drive the business.
KEY TASKS & RESPONSIBILITIES
- To define and implement the Marketing strategies, plans and policies for the Business Area Software that enable the business to meet its goals and objectives
- To develop and implement promotional initiatives both as part of the strategic planning process and in response to budgetary variances to ensure achievement of fiscal objectives
- Conduct market research as necessary to facilitate business planning
- To segment target markets and develop strategies and initiatives to fully exploit their potential
- Undertake the planning and management of the process of new product launch for Business Area Software
- Become the 'go-to' point of expertise for competitor knowledge and counter argumentation for BA Software, to include the development of effective and defensible product positionings
- Ensure regional sales organisations are fully aware of approved BA Software marketing strategies and encourage cascade within those organisations
- Develop and deliver (in conjunction with Medical Marketing Manager) comprehensive platforms of product sales support
- Collate global input from business regions and stakeholders to develop strong universally applicable marketing strategies
QUALIFICATIONS/EXPERIENCE:
- Bachelor's degree in Marketing, Business, healthcare field or similar or equivalent experience. Master's degree in business or equivalent preferred.
- 5-7 years marketing or product management experience (medical products is preferred).
- Balance of strategic and tactical abilities.
- Excellent communication skills.
- Strong interpersonal skills.
- International knowledge or experience.
Medical Physicist
Elekta CMS Software continues to be the leader in the development of computerized radiation therapy treatment planning systems. Since 1979, we have consistently grown to include 300 of the best professionals in the industry: including Medical Physicists, Dosimetrists, Software Engineers and a fabulous Support Team. Our headquarters is located in Saint Louis, Missouri, with offices in Germany, Japan, China and Australia. CMS is part of the Elekta Group, integrating in one group of companies over 2600 employees working in all the steps in the process of providing Radiation Therapy, from the Planning System to the Record and Verify and the Linear Accelerator. CMS is proud to carry the ISO, EN and CE mark certifications. CMS cares about its employees, its customers and our reason for working so diligently in our careers - the cancer patient.
This exciting and evolving field requires research and development in the areas of 3D visualization, medical image analysis, mathematical modeling of physical interactions of radiation with matter, energy transport, advanced calculation algorithms, large scale optimization problems, GUI development and much more. Our development team is excelling in meeting the challenges of the scientific and medical community. At CMS, you will have the opportunity to make a difference, to apply your skills and efforts into challenging scientific problems and see your solutions manifest in a system that will help hundreds of thousands real people around the world fight a serious disease.
Our Medical Physicists participate in the design and development of new features, algorithm testing and implementation. Our physics group works from the theoretical level to the clinical level. They have strong interaction with software engineering groups, the mathematical modeling and physical implementation of dose calculation solutions, and clinical testing of new developments. Our physicists also interact with selected customers, as well as conduct internal training of other groups in the company.
QUALIFICATIONS and EXPERIENCE
- Masters or PhD in Medical Physics or related field
- At least 3 years of clinical experience as a medical physicist
- Proficient using a PC and MS Office Suite
- Strong analytical ability; must be skilled in performing numerical analysis
- Excellent verbal and written communication skills are required
- Coding experience in C or C++ is highly desirable
- Experience with mathematical optimization of complex problems is a plus
- Minimal travel is required, both domestic and international
We have fairly flexible working hours and located in beautiful Central St. Louis County, MO. Relocation assistance is available.
Product Manager
Summary: The Product Manager (PM) is responsible for product definition, planning and direction. This role works within the realm of BASS policies and procedures, determines market requirements and plans how and when the product will meet the market needs. The PM will define the Product Requirements as one of the preliminary phases of product development. The Product Manager directs and coordinates the activities of the Development Team (department) in accordance with the approved annual Elekta operating plan to achieve objectives within approved budgets. The PM works to promote the products under their responsibility. The PM works to assist marketing in all areas of market research to include pricing, competitive analysis, promotion, advertising and sales support.
DUTIES AND RESPONSIBILITIES
- Obtains and maintains knowledge and understanding in medical physics and radiation therapy technology by attending seminars, visiting customer sites, visiting appropriate research institutions, and reading appropriate periodicals and scientific journals.
- Works with the Director of Product Management and the Business Line Management to develop product plans and strategy that support the Elekta operating plans, goals, and objectives.
- Develops Product Requirements documents or works with authors to insure that product functionality meets a balance of market need and corporate objectives.
- Communicates product plans within the department and to other appropriate Elekta personnel to ensure plans are properly implemented.
- Provides Development Teams with either direct support or clinical personnel to assist in documentation, training development teams, and reviewing requirement specifications and prototypes.
- Works directly with Global Product Support (GPS) and Education and Training (E&T) teams to get them advanced training on new releases, so they can prepare their trainings for internal and external customers.
- Assists GPS with Learning Labs where needed.
- Assists E&T with training documentation.
- Assists analysis of competitors in Elekta markets.
- Assists with preparation of regulatory documents.
- Assists in the development concepts for literature, advertising, etc.
- Provides technical documents and presentations for other departments.
- Provides technical sales support via phone and at customer sites.
- Provides representation or feedback to the Hazard Assessment Team (HAT).
- Reviews Customer Support documentation including Errata Reports.
- Assists marketing managers with market research related to new features and functionality for Elekta products.
- Works closely with customer support to plan and organize off site testing when applicable.
- Ensures that product related reports and scientific papers generated by third parties are accurate and that Elekta personnel are properly credited when applicable.
- Presents papers and other scientific presentations at conferences and industry meetings representing Elekta.
EDUCATION & EXPERIENCE:
- Bachelor's degree in Physics or related science and advanced degree(s) in business and physics or related science.
- 5+ years of business experience or Dosimetry experience in the area of Radiation Therapy may be substituted for the advanced degree requirement.
