US, York, SC Regulatory Toxicologist
We are seeking a Regulatory Toxicologist experienced with the management of biocompatibility, and other regulatory testing, for the healthcare and/or medical device manufacturing space to support our initiatives as we expand and establish new silicone manufacturing operations.
The main responsibility for the newly added position of Regulatory Toxicologist is to provide oversight for testing required to support the HealthCare Products, including Long Term Implant (such as medical devices) and Excipients business. He/she will be working in a silicone manufacturing environment where they will summarize test results and assist with the preparation of regulatory submissions. This position will provide testing support for other product types and other testing needs for regulatory registrations. The role will be primarily focused on the Americas market.
The incumbent will work closely in collaborative and team-oriented environment with our Research and Innovation and Product Stewardship/Regulatory Affairs team members to plan, execute and monitor toxicology and regulatory studies. They will be instrumental in formulating testing strategies and work plans, reviewing study protocols, monitoring studies, interpreting testing results, and utilizing results in product safety assessments. He/she will be a knowledgeable resource for toxicology and hazard assessment activities.
It is important for the qualified candidate to be knowledgeable of international and domestic testing requirements according to ISO, ICH, US EPA/FDA and other global standards to ensure that our silicone materials pass required testing. Communication skills are important to effectively communicate complex information to a variety of internal and external audiences. A key activity for this role is to assist with gathering required information for Master Files/Drug Master File filings to the US Food and Drug Association. Additionally, this position will be responsible for creating biocompatibility compendiums for sale to interested customers who must register their products outside of the US. These regulatory submissions and compendium creations require a significant amount of administration process management.
- Minimum of a bachelor’s degree in toxicology, biology, biochemistry, or related scientific field.
- Minimum of 3 years of relevant experience preferred.
- Experience with oversight of product testing for safety and regulatory evaluation, interpretation and summarization of test results.
- Experience with working with external contract testing laboratories preferred.
- Working knowledge of ISO 10993 testing and ICH guidelines a plus.
- Understanding of toxicological and product stewardship/regulatory affairs principles & their application to the industrial environment.
- Strong analytical and evaluation skills.
- Experience working as a member of cross-disciplinary and international teams,
accomplishing things by working through impact and influence.
- Proven high level verbal and written communications skills. Candidates must have experience translating science, toxicology and risk into understandable and balanced communication to other toxicologists, as well as to both scientific and non-scientific audiences who may be internal to the Company, clients or the general public.
- Working knowledge of MS Office tools.
- Exposure to a range of regulations such as European REACH, US TSCA, UN and OSHA GHS and relevant local regulations. Experience working with the FDA is preferred.
- Periodic Travel (<15%)
Elkem will conduct a post-offer background check to confirm the information provided by candidates during the recruitment process. Additionally, a post-offer physical, including a substance screening, is required. Relevant candidates will be informed of this if it applies.
We are an Equal Opportunity Employer – M/F/Veteran/Disabled and if you are an individual with a disability, who requires an accommodation, please contact us.
To Apply: Please send a cover letter and resume to NACareers@Elkem.com. Please refer to the Position Code in the Subject line.
Note: We conduct background checks of candidates in our recruitment process.
- Region: North America
- Division: Silicones
- Job type: Compliance
- Working hours: Full Time
- Working days:
- Application deadline: 31.05.2021
- Location: York, SC