Senior RA Manager
1 week ago
This senior-level position involves leading regulatory affairs efforts for a prominent medical equipment manufacturer based outside Portland.
The successful candidate will develop and implement regulatory strategies for both new and existing products, ensuring compliance with global market regulations.
Responsibilities:
- Develop comprehensive regulatory plans for global markets, focusing on new and established products.
- Manage and prepare regulatory submissions for various markets.
- Maintain up-to-date regulatory documentation and registration records.
- Act as a subject matter expert on regulatory affairs within cross-functional teams.
- Ensure ongoing compliance with international medical device regulations throughout the product lifecycle.
- Lead post-market surveillance activities and manage regulatory reporting.
Qualifications:
- Bachelor's degree in a STEM field or equivalent experience.
- A minimum of 7 years of experience in regulatory compliance for Class I and II medical devices.
- Knowledge of relevant medical device regulations, including ISO 13485:2016, Australia TG(MD)R, Brazil RDC 665, Canada MDR, EU MDD/MDR, Japan MHLW MO 169, US FDA 21CFRs, and more.
- Excellent technical writing and communication skills.
- Proven ability to manage multiple projects and prioritize effectively.
The estimated annual salary for this position is $122,000, considering the location and industry standards.
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