Robert Half International Senior Regulatory Specialist in Santa Barbara, California
Robert Half Direct is seeking a remote Senior Regulatory Specialist for a medical device company to implement regulatory strategies and provide guidance on regulatory issues. The successful Senior Regulatory Affairs Specialist will have a solid and in-depth knowledge of global medical device regulations, standards and guidance documents, as well as regulatory compliance requirements. This position will also responsible for preparation and submission of documentation for regulatory registration of the company's products and will serve as a role model in the areas of regulatory, leadership, teamwork, customer focus and continuous improvement.
Additional Duties and Responsibilities:
• Develop and implement 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
• 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
Robert Half Finance & Accounting matches skilled professionals with remote or on-site jobs in accounting, bookkeeping, finance, audit, taxation and more on a full-time basis. Our experienced staffing professionals can promote you to employers and advocate on your behalf. We provide access to top jobs, competitive compensation and benefits, and free online training. For more opportunities, get the Robert Half app and receive instant notifications when our AI matches your skills and experience with jobs.
When you work with us, you’re working with the best. Robert Half has been recognized as one of FORTUNE’s “Most Admired Companies” every year since 1998 and was No. 1 on Forbes’ annual ranking of America’s Best Professional Recruiting Firms.
Questions? Call your local office at 1.888.490.5461. All applicants applying for U.S. job openings must be legally authorized to work in the United States.
Salary: $100,000.00 - $125,000.00 / Yearly
Location: Santa Barbara, CA
Date Posted: January 12, 2021
Employment Type: Full-time
Job Reference: 31000-9502814964
Staffing Area: Full-Time Accounting u0026 Finance