Subject Matter Expert

Date: Nov 16, 2020

Location: BU, HU

Company: ArisGlobal

ArisGlobal is a dynamic and growing global software company dedicated to serving the life sciences (pharmaceutical, biotechnology and medical device) companies in the management of their clinical trials, drug safety and regulatory information. Our global team – located in major corners of the world – includes some of the industry’s leading authorities, subject matter experts and experienced professionals in their respective areas of life sciences. All are focused on advancing our innovative and market-proven solutions and services.

 

"Are you are looking for a career where your involvement can make a difference?" We are growing fast and always looking for people with the best blend of experience, knowledge, talent and ambition. If you are committed to making a difference and have the skills and experience to make things happen then JOIN US.

 

Overview

Located in our Germany or Hungary office, this position is part of the globally located on our Regulatory Product Strategy and Management team, and provides expert knowledge-based input to Product Management, Sales, Marketing and Global Delivery (GD) teams in support of the company’s primary mission of expanding revenue and revenue opportunities, in line with overall company strategy.

 

The primary function of the Medical Device - Subject Matter Expert (SME) is to bring customer facing and industry thought leadership experience to ArisGlobal’s product offerings from an outside-in perspective. The ideal Medical Device - SME will be a seasoned industry expert familiar with requirements of medical devices and the associated technologies. Additionally, the candidate will have an established track record of working alongside Project/Product Managers and clients/contracts to understand and develop a regulatory path with acceptable risk. The Medical Device - SME will understand regulatory implications of technologies, assisting on project tasks, and creating a solution strategy and elicit business requirements for the Medical Devices domain.

 

Essential Duties and Responsibilities

  • Conduct market surveys of medical device/diagnostic technologies against public health emergency response need and understanding the ramifications of technologies to environment, ease of use, and ultimate clinical usage requirements/satisfaction.
  • Assist in technology selection from administration through review of technical proposals and providing recommendations to the project management team.
  • Understand regulatory implications of technologies and assist the Project Manager and contracted manufacturer in developing a feasible and economical regulatory path with acceptable risk.
  • Assist in the development of project plans – task to schedule and then monitor progress periodically for compliance.
  • Assist in the management of contract to include assessment of contracted device manufacturer progress, technology or schedule risk identifications, and resolution recommendations.

 

Requirements: Education, Experience & Skills

The SME is a specialist role that requires self-motivation, the ability to communicate at all levels of an organization and an excellent understanding of both industry and software.

  • Bachelor’s degree in Life Sciences, Bio, Pharma or Related
  • Min of 3 years in Life Sciences, SaaS, Pharma, Bio-Tech or Medical Device in Regulatory
  • Must work well with others in person or virtual and have a knack for understanding needs and problems.
  • Proven ability to influence cross-functional teams at all levels of leadership is a must.
  • Excellent communication skills both written and verbal required.
  • Visual way of presenting nebulous ideas and complex concepts in a simple way is considered as a key aspect of communication in this role.
  • Effective time management & multi-tasking skills.
  • Ability to analyse and relate customer issues/requirements to ArisGlobal software solutions.
  • Self-managed, self-starter, able to work in rapidly changing environment.
  • High energy, detail oriented and creative individual.
  • Ability to work both independently and cohesively in a team environment.

 

<span style="font-family:"Arial",sans-serif">Benefits

<span style="font-family:"Arial",sans-serif">As a full-time employee of ArisGlobal, you will have the option to participate in various benefit programs as you meet the respective eligibility criteria. Some of the more significant ArisGlobal benefits and programs include:

  • <span style="font-family:"Arial",sans-serif">Eligible to participate in the ArisGlobal 401(k) program administered by ADP: 1st pay-period
  • <span style="font-family:"Arial",sans-serif">401(k) - First 3% match capped at max $4,000 EMR annually
  • <span style="font-family:"Arial",sans-serif">Cigna Insurance for health, vision, and dental: starts day 1!
  • <span style="font-family:"Arial",sans-serif">Paid Maternity/Paternity Leave
  • <span style="font-family:"Arial",sans-serif">Employee referral programs - $1000+
  • <span style="font-family:"Arial",sans-serif">Paid time off, holidays, and floating holidays (20 + days)
  • <span style="font-family:"Arial",sans-serif">Flexible spending accounts + HSA's
  • <span style="font-family:"Arial",sans-serif">Non-medical insurances + Teledoc (pet insurance optional, included!!)

 

<span style="font-family:"Arial",sans-serif">ArisGlobal<span style="font-family:"Arial",sans-serif"> proudly offers an Impressive Package of Compensation and Benefits. In addition to competitive salary compensation and paid time off, eligible employees receive health care benefits and can participate in healthcare and dependent-care spending accounts that reduce out-of-pockets costs by reducing taxable income. Income protection and wealth accumulation benefits help our employees reach their long-term financial goals.

 

 

<span style="font-family:"Arial",sans-serif">*ArisGlobal is an Equal Employment Opportunity Employer and considers all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, age, marital status, national origin, protected veteran status, disability, or any other legally protected class.