Clinical Specialist- Pelvic Health

This position is remote, and strong phone and internet capabilities are required.

Clinical - Innovative - Caring - Global Collaboration - Winning Spirit - Results Driven -Motivated

Pelvic Tech is revolutionizing the pelvic device industry. Run by pelvic floor clinicians, the aim is to bring the most effective and innovative devices to clinicians and patients alike. A startup company committed to providing the necessary tools, each item has been carefully selected because of its proven efficacy.
 

At Pelvic Tech, you’ll discover a fast-paced environment, where you can find meaningful purpose, improving lives through your life's work. We are looking to make a difference in the pelvic health world- breaking down stereotypes and providing opportunities. Concerned with work/life balance, we want to ensure that our employees are able to offer the proper dedication during working hours.

About the role:

This position's main contribution is to offer clinical support in the acquisition of new devices, connecting with manufacturers and offering support to clinicians and patients.

Your responsibilities may include:

• Identify the most effective pelvic devices for clinicians and patients
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations and pelvic devices.
• Complete regulatory assessments for design and process changes and coordinates and manages product distribution controls to set up and define rules for all required product control.
• Assists manufacturing and development teams, providing regulatory feedback and guidance throughout the product integration for any product changes, and coordinating team inputs for submissions.
• Proficient in Excel to create, manage and coordinate required regulatory information fields for required device listings.
• Work with International manufacturers to adhere to regulatory requirements.
• Assists teams to migrate advertising and promotional material into BSC processes/systems.
• May assist professional and technical staff with special projects.
• Provide data and information to other functions on processes and procedures, as requested.
• Uses software for functional area, to compile and generate reports, statistics, timelines, tables, graphs, correspondence and presentations.
• May design processes to enhance work flow.
• Provides data and information to others on functional unit processes and procedures.

What we’re looking for in you:

Required Qualifications:

• A minimum of a Bachelor’s degree or equivalent combination of education and experience
• A minimum of 3 years’ of clinical experience or in the medical device, pharmaceutical, and/or health care industries
• Proficiency with Microsoft Office, (i.e. creating formulas, v look up, pivot tables and working with multiple worksheets in Excel; using captions, cross references and inserting graphics, charts and tables in Word; creating forms, queries and reports in Access)
• General understanding of product development process documents, international standards and pelvic devices
• Able to review standards and how devices will match them
• Ability to manage several projects simultaneously
• Able to answer questions about product usage
• Effective research and analytical skills
• Effective written and oral communication, technical writing and editing skills
• Ability to work independently with minimal supervision

Your responsibilities may include:

• Identify the most effective pelvic devices for clinicians and patients
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations and pelvic devices.
• Complete regulatory assessments for design and process changes and coordinates and manages product distribution controls to set up and define rules for all required product control.
• Assists manufacturing and development teams, providing regulatory feedback and guidance throughout the product integration for any product changes, and coordinating team inputs for submissions.
• Proficient in Excel to create, manage and coordinate required regulatory information fields for required device listings.
• Work with International manufacturers to adhere to regulatory requirements.
• Assists teams to migrate advertising and promotional material into BSC processes/systems.
• May assist professional and technical staff with special projects.
• Provide data and information to other functions on processes and procedures, as requested.
• Uses software for functional area, to compile and generate reports, statistics, timelines, tables, graphs, correspondence and presentations.
• May design processes to enhance work flow.
• Provides data and information to others on functional unit processes and procedures.

Required Qualifications:

• A minimum of a Bachelor’s degree or equivalent combination of education and experience
• A minimum of 3 years’ of clinical experience or in the medical device, pharmaceutical, and/or pelvic health care industries
• Proficiency with Microsoft Office, (i.e. creating formulas, v look up, pivot tables and working with multiple worksheets in Excel; using captions, cross references and inserting graphics, charts and tables in Word; creating forms, queries and reports in Access)
• General understanding of product development process documents, international standards and pelvic devices
• Able to review standards and how devices will match them
• Ability to manage several projects simultaneously
• Able to answer questions about product usage
• Effective research and analytical skills
• Effective written and oral communication, technical writing and editing skills
• Ability to work independently with minimal supervision

All your information will be kept confidential according to EEO guidelines.