Remote Medical Device Regulatory Affairs Manager
Kforce Inc.

Job Info

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RESPONSIBILITIES:

Kforce's client, a growing Medical Device Company in Encinitas, CA, is seeking a Remote Senior Regulatory Affairs Specialist or Manager. This position is 100% remote. This company offers a competitive compensation package including base salary, annual bonus, etc. We are working directly with the Hiring Manager on this exclusive search assignment. The Medical Device Regulatory Affairs Manager will have direct responsibility for developing regulatory plans with high level of complexity. This role prepares documentation for international and domestic product registrations for new and modified products. The Medical Device Regulatory Affairs Manager interacts with governmental regulatory agencies, other third-party accrediting bodies, and US trade associations. This role would not have an immediate team to manage however as the role grows, this is a possibility.Responsibilities:

• Create regulatory plan to improve the development and commercialization of medical device products through approval and life-cycle management
• Prepare documents for regulatory submissions and registrations including but not limited to FDA, EU and other foreign regulatory bodies
• Support compliance activities associated with the Quality Management System to fulfill with international and domestic policies and regulations
• Review modifications to existing products, SOPs, test methods, process changes, design changes, and field concerns
• Writes and maintain regulatory design documents, technical files, device master records, design history files
• Support new product launch, risk management activities, regulatory plans, product V&V, process validations, and design transfer into manufacturing
• Regulatory assessments of customer complaints and reportability (MDR & MDV)
• Maintain present awareness of FDA and global regulation, guidance, and standards applicable to company products
• Comply with all safety policies, practices, and procedures

REQUIREMENTS:

• BS or MS in any scientific field, engineering or regulatory affairs or similar field
• At least 5-10+ years of experience in Regulatory Affairs within a Senior Specialist or managerial role
• Strong knowledge of federal and international regulations
• Strong knowledge of quality systems in a regulated manufacturing environment
• Demonstrated written and verbal communication skills
• Ability to work on multiple projects simultaneously
• Possess a high degree of accuracy and attention to detail
• Experience with PMA (Premarket approval) would be ideal
• Experience with MDD to MDR conversions would be preferred
• Experience with Class 2 or Class 3 medical devices would be ideal
• Will consider a Regulatory Affairs specialist or Regulatory Affairs Manager
• Will also consider candidates out of the Dental or Pharmaceutical industries

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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