RA Specialist III - United States
Want to know company name or location? Company managed [?]
What you'll be doing:
- Regulatory Affairs Representative III is responsible for:
- Support of design control projects.
- Domestic and international regulatory submissions to assure timely release of new products to market worldwide.
- Provide regulatory support of currently marketed products.
- Preparation of Technical files to support notified body submission.
- Evaluation of adverse incidents and MDR filing.
- Prepare Health Hazard Evaluations and coordinate product quality notifications.
- Oversee SAP product restrictions.
- Support of design validation studies.
- Clinical laboratory experience or equivalent IVD industry RA, R&D, QA or production experience.
- Effective communication skills (written and verbal).
- Ability to critically review and summarize product performance data.
- Logical thinking, tact and negotiation skills, and customer orientation.
- Bachelor’s degree in biology, chemistry, medical technology or related field.
- Advanced degree and Regulatory Affairs Certification are preferred.
- 5+ years of experience in domestic and international regulatory compliance in the medical device industry.
- Working knowledge of FDA and CE Mark requirements.
- Knowledge of product labeling requirements.
- Preparation of regulatory submissions.
- International product registrations.
- Preparation of product technical files.
- Good planning and multi-tasking skills.
- Excellent computer skills.
- Strong documentation skills.
- Competitive pay and great benefits including medical, dental, vision, 401k and more.
- Opportunities for growth and training.
- Stability of a profitable 60+ year old company.
- Great work environment.
- Our company is a global leader providing a broad array of clinical diagnostics and life science research products. With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
- Our company was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
- EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age