What are the responsibilities and job description for the Regulatory Compliance Expert position at Trelleborg Medical Solutions?
About the Job:
Trelleborg Medical Solutions is seeking a skilled Regulatory Compliance Expert to join their team. In this role, you will be responsible for ensuring that all medical devices meet the required regulatory standards.
Main Responsibilities:
- Collaborate with New Product Development (NPD) teams to support equipment qualification, software validation, test method development/validation, process development/validation (IQ/OQ/PQ), and other quality processes to ensure compliance with the company's Quality System and applicable external requirements and standards.
- Develop and execute equipment, software, test method, and/or process validation strategy in conjunction with the NPD team.
- Perform risk management by identifying, estimating, evaluating, controlling, and monitoring risk, utilizing risk tools such as Process Failure Modes and Effects Analysis (pFMEA).
- Author or approve protocols and reports for Equipment Qualification (IQ/EQ), Software validation (SV), Test Method Validation (TMV), Process validation (OQ/PQ).
Requirements:
- A 4-year degree in quality, engineering, or any related field.
- 2 years in a manufacturing environment in a technical support role.
- Desired: ASQ Certified Quality Engineer, Formal Six Sigma Yellow/Green belt training, knowledge and experience with GMP/ISO Standards: ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable).
What We Offer:
- Competitive compensation based on experience.
- Generous benefits package: Health, Dental, Vision, STD, LTD, Life, 401k.
- Paid time off.
- Bonus.
