Vacancy caducado!
Sr. Regulatory Affairs Labeling Specialist, Orange, CAPosition Overview: This Sr. Regulatory Affairs Labeling Specialist is responsible for the development and sustainment of global medical device labeling across the dental consumables business platform. This individual will be considered the subject matter expert (SME) for meeting medical device labeling regulatory requirements by applying knowledge and understanding of the regulatory and legal frameworks, requirements, legislation, processes and procedures.Essential Duties and Responsibilities:
Manages all labeling development activities for all new product development and legacy products: creates, proofs, edits, and manages labeling lifecycle(s).
Identifies and provides regulatory labeling guidance to ensure labeling development processes follow applicable regulatory, legal and organizational requirements.
Meet all medical, legal, and regulatory requirements for medical devices following the established design format, labeling style guidelines and branding guidelines.
Partners with Packaging and Labeling team for artwork creation.
Ensures change control processes are followed to maintain accuracy of change during revisions/versioning of documents.
Establishes and manages cross-functional relationships to ensure control and continuous improvement of labeling activities meet business needs and regulatory requirements.
Works cross-functionally to identify and resolve labeling inconsistencies with labeling material and requirements and to meet project objectives.
Provide regulatory information and guidance for proposed product claims/labeling.
Lead weekly Label/Claims meetings.
Ensure applicable procedures are updated and associates are trained.
Ensure clinical and non-clinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
Performs other related duties and responsibilities, on occasion, as assigned.
Job Requirements:
Bachelor's degree (BS/BSc or BA), preferably in a scientific or health-related discipline or equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated.
4-5+ years of Regulatory Affairs experience in a regulated industry, with emphasis in product regulatory labeling.
Required experience developing artwork for regulated medical products and creation and management of change requests in an electronic environment (eg. QMS system).
Thorough knowledge of global regulatory labeling requirements, GMP, and ISO guidelines.
Strong knowledge of global regulation/guidance, particularly those related to labeling and demonstrated ability to apply regulations, guidelines and regulatory processes to provide regulatory guidance.
Strong analytical and organizational skills; ability for detail and precision
Excellent written and oral communication skills
Multitasks, prioritizes and meets deadlines in timely manner
Strong interpersonal and presentation skills with the ability to influence others in a positive and effective manner
Strong computer skills in Word, Excel and PowerPoint
Strong experience utilizing Adobe Acrobat Pro
Strong experience utilizing cloud-based file sharing system(s)
Ability to schedule and organize multiple projects
Ability to work within a team and as an individual contributor in a fast-paced, changing environment
Ability to comply with constantly changing regulatory procedures and prioritize work effectively
Ability to work under minimal supervision
For immediate consideration, apply today! Questions? Call Toni at 714.454.8252 OR email at [email protected] Kelly ® ?With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.About Kelly ®At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Vacancy caducado!