Medical Device, Quality/Risk Management, Regulatory Compliance, Submission & Registration
4 Year Degree
Job Description A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Senior Regulatory Affairs Specialist role. Our client, a leading medical device company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you. Responsibilities include: 1) Develop and implement regulatory strategies 2) Prepare global regulatory files and submissions for product registrations 3) Review and approve proposed design changes 4) Prepare and oversee documentation of various projects 5) Guide and mentor junior RA professionals 6) Develop and prepare regulatory reports and presentations 7) Prepare clinical evaluations 8) Manage and oversee product recalls 9) Comply with company’s policies and procedures 10) Perform other duties as assigned Critical Requirements 1) Recent experience in the medical device industry is required 2) Preference will be given to candidates with recent experience in regulatory affairs INDH Job Type: Direct Hire Experience: submitting 510(k) to the FDA: 3 years working in FDA regulated medical device industry: 8 years • regulatory labeling: 3 years Education: • Bachelor's in Engineering preferred
This position is with our best client. The are growing (controlled) company which has it's own product in design and production and also does out-source engineering design, manufacturing and RA/QA consulting. The person most likely to be successful in this role will thrive on fast pace and diversity of both strategic and tactical work in Regulatory Affairs also in QA from time-to-time. It can also be expected that this person will work as RA or RA/QA Manager for periods of time at client companies. My personal history with this company goes back 4 decades I can guarantee the one of the core values is honesty and integrity and another is to hire only "top performers."