Biocompatibility Expert - EU

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry.

With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year.

Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality.

We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

Principal Technical Consultant

The Principal Consultant is an expert and lead in technical consults.

They will oversee, write, and research client projects to safeguard global health.

This will also include the review of all necessary written information (e.g., Product Adoptions, Test Plans, FDA Responses) from peers and any additional research or other considerations.

Location:

Salt Lake City, Utah, USA

Essential Duties for Principal Consultant:

Consulting


* Review and write assessments and other related documents (i.e.

Product Adoptions, Test Plans, FDA Responses)


* In preparation for assessment deliverable, work cross-functionally with other departments to guide where expertise is necessary


* Communicate with the client to obtain additional information for projects or related testing


* Perform literature research


* Build and implement process improvements


* Know and follow the Nelson Service Standard and Code of Ethics


* Act as a mentor to develop peer experts and as an expert to lead the scientific direction of at Nelson Labs


* Understanding of global capabilities and competencies (including networking with other facilities)


* Known as an expert in specific areas of consultation


* Expected to present at Nelson Labs seminars and other areas of presentation


* Possesses a greater diversity in the areas of consultation

Regulatory Compliance


* Know and follow applicable regulatory requirements (GMP, GLP, ISO, AAMI, ASTM, etc.).


* Participate in Committee meetings as appropriate including US ISO Delegate as appropriate.


* Present at Nelson and other seminars as appropriate


* Know and follow company policies and procedures.


* Complete required training on time.


* Leads the industry as an expert.

Professionalism


* Attend work regularly and reliably.


* Adhere to all policies and procedures.


* Perform other duties as assigned

Competencies of this position


* Excellent project management skills


* Excellent verbal and written communication skills


* Excellent technical writing skills an...