Senior Regulatory Affairs Specialist (Remote)

Bausch Health Companies Inc. Remote
senior regulatory remote regulatory management technical operations registrations engagement training medical safety r&d
November 23, 2022
Bausch Health Companies Inc.
Bothell, Washington
Position Title: Senior Regulatory Specialist


Business Title: Sr. Regulatory Specialist


FLSA Status: Exempt


Reports To: Manager, Regulatory Affairs


Principle Responsibilities and Duties:


Note: The following are meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title.


This senior professional provides direct support to Solta operations for their globally distributed products. They work closely with site Quality, R&D, Operations, and regional peers to support global licensing and registrations, and to ensure the effective execution and management of changes.


  • Acts as the primary interface between Solta and Solta s global regulatory teams
  • Supports requests for Solta product information and documentation to facilitate regional regulatory submissions
  • Evaluates product changes for impact to global markets through engagement with international Regulatory professionals, and documents results
  • Identifies and communicates new and revised international regulatory requirements to the organization, performs/coordinates impact assessment activities, and supports implementation of changes as required
  • Facilitates Global regulatory assessments through engagement with our international regulatory professionals.
  • Maintains global Solta product market approval status
  • Provides input to and supports maintenance of product technical files
  • Generates Notified Body Notices of Changes as applicable
  • Provides regulatory expertise to the R&D and Operations teams, including labeling requirements and submission approval lead times
  • Maintain and manage a complex portfolio of product and process changes. Develop, strengthen and continually improve supporting processes.
  • Support site change implementation process to ensure changes that affect ex-US markets are communicated and tracked.
  • Serves as the focal point for change requests from the various regions, along with requests for information supporting global product registrations.
  • Develops and maintains the underlying processes for this function including performance measures. Based upon system feedback, drives continual improvement in associated QPIs.
  • Helps solidify and strengthen the global Regulatory support network and process through proactive engagement with international peers and key stakeholders.
  • Provides training as required to both international and domestic team members in support of the overall process.


Experience, Education, Training, Skills, Traits:


  • This position requires a minimum of an undergraduate degree, preferably in a science related field.
  • Requires 5-7 years of experience in Regulatory aspects of development, distribution and life-cycle management of medical devices.
  • Possesses a keen understanding of Change Management / Life Cycle Management of medical device products along with the impact of such changes on global product registrations.
  • Demonstrated ability to work effectively in a self-directed, decentralized team environment of high accountability and complexity.
  • RAPs training preferred but not required.
  • Must possess knowledge of current device regulations and regulatory agency organizations.
  • Must possess good interpersonal abilities to work with peers across the organization.
  • Must possess excellent time management and organizational skills to maintain and manage a complex portfolio of changes and process demands.


Language And Verbal Skills


Ability to read, analyze, and interpret domestic and international regulatory requirements, engineering drawings and specifications, professional journals, and technical procedures. Ability to write reports and business correspondence in English. Ability to effectively present information and respond to questions from groups of peers, managers, and internal customers. Ability to clearly and concisely convey project accomplishments, obstacles, issues, and project status.


Math Skills


Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.


Analytical And Reading Skills


Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a variety of technical documentation. Ability to read technical and clinical literature and documents and extract important concepts.


Physical Requirements


May be required to perform lifting tasks of up to 30 pounds for short durations. Duties of this job may involve sitting for extended periods of time. Duties also involve daily keyboard data entry.


Work Environment


Most work will be performed in an office environment. The noise level in the work environment is usually low to moderate.


Safety


Solta Medical is committed to the health and safety of our employees. We expect that all employees will perform their responsibilities while maintaining a safe, cooperative, and productive work environment, thus ensuring the health and safety of themselves and others.

Report this job

Similar regulatory coordinator jobs in washington