Senior Regulatory Affairs Specialist (Remote)

Date: Nov 27, 2022

Location: US-WA-Bothell, Washington, US

Company: Bausch Health

Bausch Health is a global company that develops, manufactures and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics and Dentistry.  We are delivering on our commitments as we build an innovative company dedicated to advancing global health.  Each day, Bausch Health products are used by over 150 million people around the world.

 

Our approximately 7,000 employees are united around our mission of improving people’s lives with our health care products.

 

 

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.

 

 

This position may be available in the following location(s): US - Bothell, WA, US - Remote

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch Health's Job Offer Fraud Statement.

 

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