You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

Our client is seeking a Regulatory Affairs Manager whose primary responsibility will be to act as the main point of contact for registrations and listings, particularly focusing on the Canadian market. The role also includes reviewing regulatory projects as a backup.

Key Responsibilities

• Manage, coordinate, and collaborate with departments for complaint investigation
• Regulatory Administration
• Serve as LTD back-up contact for submissions, registrations, and listings
• Back-up for consultants communication
• Evaluate labeling and submissions for license amendments, faxbacks, MDEL, and MDALL
• Participate in clinical education and marketing reviews and routing
• Assist with submissions to the FDA and Health Canada for medical devices
• Conduct predicate searches for substantial equivalence table creation
• Manage new hire, annual trainings, and effectiveness checks
• Co-manage regulatory audits as scribe or audit logistics personnel
• Analyze, review, and design documents and checklists
• Maintain registrations and listings for existing products in Canada
• Support the implementation of other Quality System elements as needed
• Oversee SOP and documentation management
• Handle record-keeping
• Manage change control and documentation
• Conduct regulatory intelligence and competitive analysis research
• Escalate challenges to resolve issues
• Generate report writing and presentation creation and delivery
• Track metrics
• Collaborate with clinical, sales, customer service, and field service teams regarding equipment for direct patient care in Canada

Qualifications

• Bachelor’s degree or equivalent experience
• Experience in FDA and Health Canada submissions and audits is required

Skills

• Proficiency in Microsoft Applications (MS Office, Excel, PowerPoint, Outlook)
• Excellent organizational skills
• Emotional Intelligence
• Ability to multitask
• Positive attitude and approach to job responsibilities

Additional Requirements

Travel to and from the Canadian site is required quarterly.

Benefits

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
• Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
• 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
• Short Term Disability Insurance.
• Term Life Insurance Plan.

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.

^*This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.