Kforce's client, a growing Medical Device Company is seeking a Remote Senior Regulatory Affairs Specialist or Manager. This position is 100% Remote. The 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. You will have direct responsibility for developing regulatory plans with high level of complexity. The Regulatory Affairs Specialist prepares documentation for international and domestic product registrations for new and modified products. The candidate 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
Will consider a Regulatory Affairs specialist or Regulatory Affairs Manager
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
Will consider a Regulatory Affairs specialist or Regulatory Affairs Manager
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
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.
