 Solta Medical, Inc. is a global leader in the medical aesthetics market providing innovative, safe, and effective solutions for patients that enhance and expand the practice of medical aesthetics for physicians. The company offers products to address a range of skin issues under the industry's six premier brands: Thermage®, Fraxel®, Isolaz®, CLARO®, Clear + Brilliant™ and Liposonix®. Thermage is an innovative, non-invasive radiofrequency procedure for tightening and contouring skin. As the leader in fractional laser technology, Fraxel delivers minimally invasive clinical solutions to resurface aging and sun damaged skin. Isolaz was the first light based system indicated for the treatment of inflammatory acne, comedonal acne, pustular acne, and mild-to-moderate inflammatory acne. CLARO is a personal care acne system that is the first FDA cleared over-the-counter IPL device that uses a powerful combination of both heat and light to clear skin quickly and naturally. Clear + Brilliant is a unique, cost-effective treatment that utilizes safe, fractional laser technology to prevent and maintain early signs of aging. Liposonix is a non-surgical treatment to reduce waist circumference with advanced high-intensity focused ultrasound (HIFU) technology to permanently destroy targeted fat beneath the skin. Since 2002, approximately one million Thermage, Fraxel and Isolaz procedures have been performed in over 100 countries.
Our mission is to be the leader in developing transformational aesthetic products procedures and services; building world class brands; and providing long term value for our stakeholders.
Solta Medical is looking for dedicated individuals who thrive in a creative challenging and professional environment - where respect for the energy of new ideas diversity and teamwork can be found at every level of the organization. We create new opportunities for physicians and the patients they serve and of course opportunities for our employees to grow and thrive.
Position Title: Complaint Systems Manager
FLSA Status: Exempt
Reports To: Vice President of Quality & Compliance
Description: Hands on manager who coordinates assessment and documentation associated with investigation of product technical complaints, medical incidents/events, and/or serious adverse events leading to medical device reports or vigilance reports as well as review of clinical information for existing and new products to support technical documentation and product launches. Provides responses (phone, written and email) for inquiries from consumers and health care professionals related to Solta products in an accurate and timely manner. Develops standardized templates for responses, reviews complaint data to identify emerging trends. Responsible for accurate and timely reporting of adverse events and product malfunction complaints, provides educational support regarding actual use, intended uses and indications for use for all products, and produces required technical documentation.
Principle Responsibilities and Duties:
Note: The following are meant to be representative but not necessary all inclusive of the duties and responsibilities for this position title.
•Manage Solta Medical complaint management systems and staff.
•Responds to both written and phone inquiries from health care professionals, patients, and consumers related to Solta Medical’s products and treatment regimens.
• Compiles statistical analysis of product complaints and adverse events; prepare trend analysis,and provides management reports on the effectiveness of the complaint management system.
• Contributes to the development and maintenance of standard and custom product information responses in various formats to address vast array of inquiries.
• Participates in complaint process SOP writing and ensure that all Solta Medical employees follow written SOPs and process specifications
• Maintains complaint systems software and database. Analyze, assess and recommend IT tools for automation of the compaint management process.
• Participates in risk analysis (e.g. establishing risk documents such as hazard analysis and FMEA)
• Proactively distributes important product and/or medical information to relevant internal functions as necessary in support of product changes, safety issues and other sentinel events
• Enhances product knowledge within the Sales Force, Marketing and other departments by disseminating relevant information on a consistent basis
• Participates in audits including, internal, CAFDB, US FDA and ISO 13485:2003
• Plans, schedules, and completes projects in an aggressive “sense of urgency manner” consistent with corporate objectives
• Performs other duties as directed by management
Experience, Education, Training, Traits:
• Bachelor's degree in Engineering, Health Care or Sciences is required. Clinical experience/certification is desired.
• Two to three years experience in management of complaint management processes in the medical device industry is required.
• Understands FDA regulations and reporting requirements for medical device complaints, including MDR reports. Knowledge of EU Medical Device Directives, Canadian Medical Device Regulations and other International Regulations is desired.
• Extensive knowledge of the requirements for international quality systems, including ISO 13485, MDD, Vigilance Systems, Notified Bodies, CE marking and IEC 60601
•Experience in interacting with health care professionals, patients, and consumers to complete and close complaint investigations.
• Experience with complaint management software systems and databases.
• Must be able to review systems, processes and policies to ensure compliance with required quality system and clinical practices
• A basic understanding of statistical tools. Identifies and understands relevant trends, opportunities, needs, and market direction within the medical device industry
• Strong leadership, collaboration and development skills.
• Proactive, team player, enthusiastic, with high work ethics
•Ability to make compliance decisions independently.
•PC experience with Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point)
• High level of attention to details, capable of efficient use of time and project management skills are essential.
• Effective written and verbal communication skills.
Language and Verbal Skills
Individual must have excellent verbal skills and written communication skills and a demonstrated ability to communicate clearly and professionally.
Math Skills
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. Experience with statistics programs is a plus.
Analytical and Reading Skills
Ability to read, analyze, interpret and assist in the creation and refinement of company procedures. Ability to define problems, collect data, establish facts, draw valid conclusions and report on findings.
Physical Requirements
While performing the duties of this job, the employee may be required to perform tasks involving lifting weights of up to 30 pounds for short durations. Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision. Duties will also include air travel, both domestically and internationally.
Work Environment
Most work will be performed in an office environment. The noise level in the work environment is usually low to moderate.
Safety
Solta Medical is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe cooperative and productive work environment thus ensuring the health and safety of themselves and others.
Solta Medical, Inc. is an equal opportunity employer. |
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