Global Product Specialist - Surgical Solutions

About The Role
We are seeking a Global Product Specialist (GPS) to join our Surgical Solutions business. In this role, you will be responsible for ensuring fitness for use (FFU) for commercial products. As part of the team, you will work closely with team members from various disciplines, including marketing, sales, engineering, manufacturing, biological sciences, regulatory, clinical affairs, health economics, legal, and business. You will also engage with healthcare providers, including global key opinion leaders and physicians, to gain insights into clinical user needs to ensure fitness for use for Gore’s products.
This is fully remote position and can work from most locations within the United States.
Responsibilities
Ensure device fitness for use (FFU) throughout the product lifecycle, including defining safety and efficacy requirements in diverse applications
Accountable for waterline decisions related to FFU
Interface with external clinical customers on product usage, therapeutic needs, and clinical research activities
Propose, evaluate, and execute product lifecycle management activities related to SKU rationalization, launch, and discontinuation
Apply understanding of clinical needs, procedures, and product FFU to navigate events, risks, benefits, testing, clinical and regulatory plans
Represent product-level activities in business processes including business reviews, operational planning, and marketing planning
Utilize Gore Business System processes to manage project timelines and implement the problem solving process when needed
Support manufacturing operations to ensure product quality while promoting efficiency and product supply
Ensure timely investigation, resolution, and communication of product performance and use issues
Ensure clinical and technical accuracy of external communications (marketing materials, regulatory submissions, etc.)
Required Qualifications
Doctorate degree in engineering, science or medicine OR Bachelor’s degree in engineering or science (or equivalent professional experience) PLUS one of the following: A minimum of two (2) years’ experience as a Product Specialist (PS) or Clinical Application Specialist (CAS) OR a minimum of 4 years of product, project or technical leadership experience in medical device industry
Demonstrated experience managing multiple projects and priorities simultaneously and in ambiguous situations
Experience effectively and successfully interacting with and influencing multiple internal functions (including technical, manufacturing, regulatory, legal, sales, product specialists and marketing) as well as external partners (e.g., physicians)
Strategic thinker with demonstrated ability to resolve complex, multi-dimensional problems
Proactive work style, working both independently and as part of a team
Ability to read, interpret, and communicate scientific or clinical publications and data
Excellent written and verbal communication and presentation skills
Ability to travel extensively, up to 25% on average, up to 40% at peak times, including international travel
Desired Qualifications
Prior CAS or PS experience working with Surgical implantable medical products
Experience providing cross-regional commercial support
This role requires ongoing access to U.S. hospitals and compliance with facility-specific access policies (which may include a requirement to provide proof that you are fully vaccinated with one of the COVID-19 vaccines), vendor credentialing requirements including drug screening, background checks, immunization and training.
This position offers a remote work arrangement in the country from which the Associate is employed. Eligibility is dependent on the responsibilities of the role and business needs, and the Associate must agree to comply with Gore’s work arrangement policies.
Note: In the United States, restrictions exist for remote work from Alaska, Hawaii and Rhode Island.
What We Offer
Our success is based on the capability and creativity of our Associates, and we are proud to offer a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow.
We provide benefits that offer choice and flexibility and promote overall well-being. And in keeping with our belief that every Associate should share in the collective success of the enterprise; we provide a distinctive Associate Stock Ownership Plan in each country as well as potential opportunities for “profit-sharing”. Learn more at gore.com/careers/benefits
Gore is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a protected veteran, gender identity and expression, and any other characteristic protected by applicable laws and regulations.
Gore is committed to a drug-free workplace. All employment is contingent upon successful completion of drug and background screening. Gore will consider qualified applicants with criminal histories, e.g., arrest and conviction records, in a manner consistent with the requirements of applicable laws.
Gore requires all applicants to be eligible to work within the United States. Gore generally will not sponsor visas unless otherwise noted on the position description.

Work arrangement
No