Senior Regulatory Affairs Specialist

Profile

We are seeking a Senior Regulatory Affairs Specialist for a very important client.

Essential Duties and Responsibilities
The Senior Regulatory Affairs Specialist is responsible for implementing regulatory strategies and providing guidance on regulatory issues. The Senior Regulatory Affairs Specialist is also responsible for preparation and submission of documentation for regulatory registration of the company products. The position serves as a role model in the areas of regulatory, leadership, teamwork, customer focus and continuous improvement.
Other duties may be assigned.

Additional Duties and Responsibilities
? Develop and implement company Regulatory Program to ensure product approval and adoption within the US and international standards.
? Perform Regulatory intelligence searches, determine regulatory requirements and develop plans to comply with national laws in the US and throughout the world.
? In conjunction with regulatory consultants, plan, prepare, submit, and coordinate new product notifications, Technical Files/Dossiers, and regulatory submissions for various countries.
? Generate and coordinate the required reports for regulatory compliance.
? Maintain active files for all products registered by the company or the distributor to ensure compliance.
? Reviews labeling for regulatory compliance and proposes updates, as necessary.
? Maintains regulatory intelligence database
? Other duties may be assigned.
Requirement:
The ideal candidate will possess the following qualifications:

Requirements (Education, Certificates, Licenses, Registrations, etc.)
? Master?s Degree, preferably in a health-related field; minimum 5 years of regulatory submission preparation; or equivalent experience combination of education and experience
? 3-5 years of experience in International Regulatory submissions preferred
? Detail oriented with excellent documentation skills, including record maintenance and traceability
? Strong verbal communication and written correspondence skills
? Effective research and analytical skills
? Strong technical writing and editing skills required
? In-depth knowledge of global medical device regulations, standards and guidance documents, as well as regulatory compliance requirements
? Ability to work as part of a project team, as well as independently
? Excellent prioritization and organizational skills with ability to work on multiple tasks/projects in a fast-paced environment

Language Skills
Ability to read, analyze and interpret technical procedures or governmental regulations. Ability to write reports or business correspondence.

Computer Skills
Ability to use word processing, spreadsheet and database applications. Ability to learn various software programs. Ability to work with data processing and programming.

Physical Demands and Work Environment
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of the job, the employee is regularly required to sit, talk and hear, lift and/or move up to 10 pounds, stand, walk, climb or balance in conditions that include stairs, uneven ground, walking between buildings, etc. Normal vision is required for this job (with corrective lenses if necessary). The work environment is somewhat quiet.
How to Apply:
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