Career Opportunities
Position: Department: Location: |
Senior Regulatory Affairs Specialist Regulatory Affairs Santa Barbara, CA |
About Sientra
Headquartered in Santa Barbara, California, Sientra is a diversified global medical aesthetics company and a leading partner to aesthetic physicians. The Company offers a suite of products designed to make a difference in patients' lives by enhancing their body image, growing their self-esteem, and restoring their confidence. Sientra has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes.
Our leadership is driven by decades of experience and skill that help bring your goals and aesthetic visions to life. We believe that shared expertise and values are essential components of success. We are seeking exceptionally talented and motivated people to join our team. If you are looking for a career that is both challenging and rewarding, and to work for a company at the forefront of the aesthetic industry, please check out our available opportunities. We look forward to hearing from you!
Essential Duties and Responsibilities
The Senior Regulatory Affairs Specialist is responsible for implementing regulatory strategies and providing guidance on regulatory issues. The Senior Regulatory Affairs Specialist is also responsible for preparation and submission of documentation for regulatory registration of Sientra products. The position serves as a role model in the areas of regulatory, leadership, teamwork, customer focus and continuous improvement. Other duties may be assigned.
Additional Duties and Responsibilities
- Develop and implement Sientra’s Regulatory Program to ensure product approval and adoption within the US and international standards.
- Perform Regulatory intelligence searches, determine regulatory requirements and develop plans to comply with national laws in the US and throughout the world.
- In conjunction with regulatory consultants, plan, prepare, submit, and coordinate new product notifications, Technical Files/Dossiers, and regulatory submissions for various countries.
- Generate and coordinate the required reports for regulatory compliance.
- Maintain active files for all products registered by the company or the distributor to ensure compliance.
- Reviews labeling for regulatory compliance and proposes updates, as necessary.
- Maintains regulatory intelligence database
- Other duties may be assigned.
Requirements (Education, Certificates, Licenses, Registrations, etc.)
- Master’s Degree, preferably in a health-related field; minimum 5 years of regulatory submission preparation; or equivalent combination of education & experience
- 3-5 years of experience in International Regulatory submissions preferred
- Detail oriented with excellent documentation skills, including record maintenance and traceability
- Strong verbal communication and written correspondence skills
- Effective research and analytical skills
- Strong technical writing and editing skills required
- In-depth knowledge of global medical device regulations, standards and guidance documents, as well as regulatory compliance requirements
- Ability to work as part of a project team, as well as independently
- Excellent prioritization and organizational skills with ability to work on multiple tasks/projects in a fast-paced environment
Language Skills
Ability to read, analyze and interpret technical procedures or governmental regulations. Ability to write reports or business correspondence.
Computer Skills
Ability to use word processing, spreadsheet and database applications. Ability to learn various software programs. Ability to work with data processing and programming.
Physical Demands and Work Environment
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of the job, the employee is regularly required to sit, talk and hear, lift and/or move up to 10 pounds, stand, walk, climb or balance in conditions that include stairs, uneven ground, walking between buildings, etc. Normal vision is required for this job (with corrective lenses if necessary). The work environment is somewhat quiet.
This description contains the essential functions necessary to evaluate the position. It is not intended and should not be used as an exhaustive list of all responsibilities, skills or efforts.
FLSA Status: Exempt
If you would like to apply for this position, please email your resume to careers@sientra.com.