Solta Medical, Inc. (SLTM) 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: Senior Regulatory Affairs Specialist

Description:The Regulatory Specialist will support the Regulatory and Compliance objectives related to product development. Primary task areas include regulatory and documentation support for all projects and submissions required by medical device state, federal, and international standards. 

Reports To: Senior Director, Regulatory and Clinical

Principle Responsibilities and Duties:
Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.


• Compile and format departmental documentation for inclusion in regulatory submissions (IDE, 510(k), International Registrations).
• Participate in the complaint management process and ensure timely completion of adverse event reporting as required by the FDA and international regulatory agencies.
• Works closely with the Sr. Director of Regulatory and Clinical and related departments in order to support Regulatory submission activities.
• Coordinate and consult with other departments, including Engineering, Manufacturing, Marketing and Quality, in order to support the collection of documentation, review and assembly of regulatory submissions.
• Ensure the quality, content and format of regulatory submissions to state, federal and international agencies.
• Ensure consistency, completeness and adherence of standards for all submissions. Submissions will include: IDEs, 510(k)s, federal and state establishment licensing applications, international regulatory device licensing applications, etc.
• Maintain file documentation and records of annual reports and correspondence with state, federal and international regulatory agencies.
• Assist with the review of promotional materials to support the Sales and Marketing departments

Experience Education Training Traits:

• Bachelor's degree in physical/biological sciences or equivalent.
• Minimum of 5 years of regulatory experience
• Minimum of 5 years of medical device industry experience
• Excellent organization skills and attention to detail
• Computer skills are needed, with experience using Microsoft Access, Word, Excel and PowerPoint software programs.
• Requires strong written, oral, interpersonal, group, and telephone communication skills.

 Language and Verbal Skills:

Individual must have excellent verbal 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.

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 lifting tasks of up to 10 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.

Work Environment:

Most work will be performed in the field in an office or clinical 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.