Duties & Responsibilities:
- Prepare, compile and publish electronic pre-market and post-market regulatory submissions
- Compile Technical Files and Design Dossiers for IVD medical devices to support EU CE-Mark Interact with business partners to support WW submissions for IVD medical devices (Asia PAC, Mexico, Brazil, Canada etc.).
- Develop and execute submission strategies for assigned projects.
- Monitor progress on key project deliverables and provide status updates on regular basis.
- Review of product labeling, literature and Web site for accuracy, consistency and regulatory compliance Develop and/or revise regulatory procedures
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:
- Demonstrated ability to coordinate complex projects.
- Strong oral and written communication and presentation skills
- Solid working knowledge of the US Regulations and European IVD and medical device directives
- Good analytical and problem-solving skills.
- Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
- Experience with International submissions and IVDs highly desirable Capacity to communicate regulations to technical functions within the company
- Ability to manage relationships with international customers (e.g., regulatory agencies, distributors, etc.)
- Solid computer skills in Microsoft Office
Education & Experience:
- Bachelor’s degree required in the life sciences or engineering with a minimum of 2 – 4 years direct experience in Regulatory Affairs (within an IVD industry preferred).
- International RA experience preferred or a minimum of 1-year direct experience in Regulatory Affairs within the IVD Industry
Preferred Specialized Knowledge:
- Understanding of FDA and European Medical device and IVD regulations.
- Working knowledge of the medical device product lifecycle.
- Product design and manufacturing change assessments for regulatory reporting.
- International regulations and submissions