Regulatory Affairs Specialist jobs in South Carolina

General Summary of the Position

The Regulatory Associate II is responsible for overseeing Rhythmlink Regulatory Affairs in the development, implementation, and maintenance of processes and records for domestic and international regulatory compliance. This role supports global regulatory compliance through periodic regulatory submissions, support of external and internal audits, generation and maintenance of technical documentation, and regulatory project management. Success in this role is measured by compliance verified through audits, approval to distribute product lines in global markets, maintenance of current market authorization. This role will participate on multidisciplinary teams to establish appropriate technical documentation and ensure compliance to regulatory requirements.

Essential Functions

(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills, and other characteristics. This list of tasks is not a comprehensive listing of all functions and tasks performed by this position. It does not imply that this position performs all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)

• Acts as Global and/or U.S. Regulatory Lead by preparing documentation for regulatory deliverables, including investigation of new or revised regulatory landscapes, preparing regulatory strategies, and/or determining impact on current product with market authorization.
• Manages regulatory strategies, submission activities, and maintenance of 510(k), IDE, PMA, EU Technical Documentation Files, Canadian Licenses, international registrations, including amendments, supplements, and regulatory requests for additional information for new product development activities and maintenance of existing approved products.
• Provides cross departmental regulatory support and compiles regulatory documentation including change assessments, for new product development and product modifications to existing product families.
• Provides regulatory expertise to Research and Development teams to support the design and analyses of projects. Interacts with cross-functional groups to ensure alignment of technical activities with regulatory strategies and requirements.
• Utilizes scientific methodology when interfacing with technical and project design teams to guide the scope of experimentation and selection of data needed to support regulatory submissions.
• Ensures that technical documentation for regulatory submissions meets the appropriate standards and content requirements, including planning, implementation, and maintenance for emerging and/or changing global regulatory requirements.
• Develop, monitor, and provide leadership for Quality and Regulatory Strategic Plans that may include cross-functional teams, to ensure deliverables are met within defined timelines.
• Advises cross-functional teams on regulatory aspects of product development and/or lifecycle management. Identifies risk areas and develops alternative courses of action including anticipation of regulator response through scenario planning and development of contingency plans.
• Maintains the Quality Management System as State of the Art.
• Participate and present as Subject Matter Expert (SME) in internal audits, external audits, or regulatory inspections.
• Review and approve labeling, promotional materials, product, and/or documentation for new products and product modifications for existing product families.
• Maintain and update regulatory processes and procedures and follow all work/quality procedures to ensure quality system compliance, training requirement fulfillment, and high-quality work.

Knowledge, Skills, and Abilities

• Knowledge of ISO 13485, 21 CFR 820, EU MDR, and MDSAP
• Knowledge of Engineering Change Control and Document Control procedures and practices
• Ability to self-prioritize and remain self-motivated
• Ability to manage a large number of projects without loss of accuracy or sense of urgency on any
• Unwavering attention to detail
• Ability to work independently or as an integral part of a cross-functional team
• Strong aptitude for reading, understanding, communicating, and applying complex and detailed guidelines and requirements from multiple agencies in multiple countries
• Strong aptitude for reading, understanding, communicating and applying complex and detailed guidelines and requirements from multiple agencies in multiple countries
• Ability to work and influence people in various levels, departments and functions in the company
• Strong verbal and written communication skills
• Ability to maintain a professional, courteous, and positive demeanor in all situations

Education, Training, and Experience

or

Preferred Experience

• Certified Regulatory Affairs Professional (RAC – Devices)
• Certified Project Manager
• Lean Six Sigma Green or Black Belt

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Additional responsibilities and duties will be required depending on a variety of factors.