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European Union Regulatory Affairs, Medical Device, Quality/Risk Management, Regulatory Compliance
Position: Senior Regulatory Affairs Specialist
Reports to: Executive Director, Regulatory Affairs & Clinical Operations
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.
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.
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.
Job Type: Full-Time, Exempt
Master’s Degree, preferably in a health-related field
Minimum 5 years of regulatory submission preparation or equivalent 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
Ability to use word processing, spreadsheet and database applications. Ability to learn various software programs. Ability to work with data processing and programming.
Ability to read, analyze and interpret technical procedures or governmental regulations. Ability to write reports or business correspondence.
Internal Number: 001
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.The Company’s Breast Products Segment includes its OPUS® breast implants, the first fifth generation breast implants approved by the FDA for sale in the United States, its ground-breaking Allox2® breast tissue expander with patented dual-port and integral drain technology, and BIOCORNEUM® the #1 performing, preferred and recommended scar gel of plastic surgeons(*). The Company’s miraDry Segment, comprises its miraDry® system, which is approved for sale in over 40 international markets, and is the only non-surgical FDA-cleared device for the permanent reduction of underarm sweat, odor and hair of all color.
At Sientra, we believe that shared expertise and values are essential ...components of success. Our leadership is driven by decades of experience and skill that help bring your goals and aesthetic visions to life. 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 out available opportunities.