United States, Los Angeles, CA, United States, San Francisco, CA, Adhesive Technologies
Global Compliance Coordinator - Remote
HENKEL IS FOR THOSE WHO STEP UP. DO YOU?
At Henkel, you can make a difference and craft your career. That’s why you own your projects and take full responsibility from an early stage. Our unique brands in markets around the world open up countless opportunities to follow your convictions and explore new paths. If you have an entrepreneurial mindset that allows you to always think out of the box - take the chance and shape the digital future together with us.
- Raw Material Management: Liaise with Purchasing and Supplier outreach to gain necessary information for new raw material setup. Manage loading and data maintenance for SAP and Albert (RSNs/formulas). Liaise with Global Trade for RM review.
- SDS Submission (Albert to SAP), Management of Change (Formulation/rm/supplier levels) and Management of restrictions (i.e. putting locks on certain activities for certain products)
- Sampling Process Management: Work closely with Dangerous Goods Shipping and Global Trade to execute export checks, PO creation for samples and expedites, regulatory restrictions management (SAP Substance Volume Tracking (SVT) cross-check), and management of labels strategy (eg On Demand)
- Management of supplemental record-keeping: Chemical specific data, SNUR, TSCA no, LVE, Volume restrictions, SVT, TSCA 12B, etc, feedback to PD, PM, PSRA as required
- Quality Management System responsibility (including Manual and Audits)
- Awareness / support of FDA(k) filing for medical devices and ensure workflows aligned to FDA / ISO standards for med. Devices predefined processes
- ISO 13485 responsibility as management representative (assure Quality Management System is effective and promote awareness if regulatory and QMS requirements throughout the organization), ISO1421 CFR Part 11 Compliance, and FDA21 CFR Part 820
- Bachelor degree in Chemistry, Biology, Toxicology or related field
- 5 – 10 years experience on PSRA mgmt.
- Cross Regional Regulatory & FDA Knowledge; Knowledge of SAP EH&S
- Familiarity with: FDA21 CFR Part 820, ISO 13485:2016, ISO 14971:2019
- Experience in professional level position in business
- Multiple project management skills while effectively communicating to senior staff
- Excellent written, oral communication and computer skills
- If remote, position would require some travel for audits
Henkel is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, age, sexual orientation, gender identity and expression, and other legally protected characteristics.
Henkel does not accept unsolicited resumes from search firms or employment agencies. Unsolicited referrals and resumes are considered Henkel property and therefore, Henkel will not pay a fee for any placement resulting from the receipt of an unsolicited referral. At Henkel’s request only, preferred vendors may be invited to refer talent for specific open positions. In these cases, a fully-executed agreement with Henkel must be in place and current.
All employees applying for an internal position must have a discussion with his/her manager about their interest in a job posting opportunity. The discussion will not preclude the employee from interviewing if their skills meet the job requirements.