Regulatory Affairs Senior/Principal Specialist
Job description
The CardioFocus culture is a dynamic, fast-paced, multi-project delivery culture. At CardioFocus we are redefining the role of regulatory in being collaborative and technically empowered. The individual contributor of our regulatory team brings knowledge and capability with global regulatory requirements and integration solutions and, importantly, an expanded technical ability/experience in engineering specific to invasive medical devices, software, hardware, and materials science.
As a contributor to the team, you will:
Drive regulatory and technical collaboration for multiple R&D and manufacturing projects.
Develop and execute regulatory strategies for pivotal clinical trials and commercialization.
Be Global Submission capable.
Formulate, conduct data/document collection, and author technical responses for audits and submissions.
Minimum Qualifications
BS in Science or Engineering
Technical experience with software, electronics, mechanical, and materials.
5 – 7 years of regulatory experience in medical devices, with preference given to electrophysiology or cardiology.
FDA Class II and III and EU MDR Class I, IIb, and III supplement experience.
FDA and EU Notified Body Audit Experience.
Use of FDA Submission systems.
Experience with EU EUDAMED, Authorized Reps, and Importers.
(If you do not meet the MINIMUM QALIFICATIONS, please do not apply.)
PREFERRED BACKGROUND
Class III device experience with preference given to electrophysiology or cardiology.
Small, dynamic company experience / culture.
Clinical Experience.
IEC standards, Biocompatibility, and Sterilization.
Review of Sales literature and promotional material.
PMDA experience.
SKILLS AND ABILITIES REQUIRED
MUST BE SKILLED in technical communication.
MUST BE SKILLED in MS Office Suite and Adobe Pro with advance features.
Demonstrated leadership and career abilities and the ability to translate regulatory requirements into clear direction for the company.
Must collect and organize diverse information to develop regulatory strategies, guide the organization, and anticipate regulatory needs and fulfill them proactively.
Must support regulatory submission activities for company partners worldwide.
Must prioritize and plan work activities, use time efficiently, plan for additional resources, set goals and objectives, organize or schedule other people and their tasks, and develop realistic action plans.
Must write clearly and informatively; edit work for spelling and grammar; vary writing style to meet needs; present numerical data effectively; be able to read and interpret written information.
Must have a basic technical aptitude to assist in processing complex technical information and clinical and test data and translate complex information into clear, concise regulatory submissions.
Wage Range: $120,000–140,000 annually
The above information on this job description is designed to present the most essential job duties and responsibilities necessary to achieve the job's end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.
Please submit your resume and cover letter to: careers@cardiofocus.com
We do not accept unsolicited resumes from recruiters or employment agencies. Any unsolicited resumes received will be considered the property of CardioFocus, Inc., and we will not be obligated to pay any referral fee unless a prior written agreement is in place.