Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
Post : Regulatory Affairs Associate
Job Description
JOB SUMMARY:
The Regulatory Affairs Associate is responsible for world-wide regulatory submissions in support of product clearances/registrations and approvals, management of all licensing and applications for the assigned business unit’s products including UDI submissions/uploads.
ESSENTIAL RESPONSIBILITIES & ACCOUNTABILITIES:
• Prepare and submit dossiers to register new products, amend current product registrations and re-register existing product registrations with foreign agencies.
• Prepare, maintain and update Device Technical Files in support of CE mark for EU products.
• Prepare and submit Certificate to Foreign Government applications with the FDA.
• Facilitate administrative and technical phases of regulatory submission, including coordination of legalization activities of documents.
• Perform review and regulatory approval of product labels and promotional materials ensuring compliance with US FDA and EU requirements.
• Ability to represent the RA department in team meetings, effectively interacting with manufacturing, Product Development/R&D, Sales/Marketing, Operations, and QA (as applicable) to meet project deadlines
• Review and assess regulatory and compliance requirements for potential new products, design changes and manufacturing process changes.
• Ability to adhere to time sensitive registration requests and deadlines to ensure global sales opportunities are met.
• Proven ability to take the initiative to independently research various international regulations and formulate and communicate a comprehensive report based on research findings.
• Implement and maintain UDI identifiers and/or labeling and manage and maintain GUDID upload to FDA system to ensure regulatory effective dates are met.
• Requires regular, reliable attendance.
• Participates in special projects and performs other duties as required.
Candidate Profile
Associate Degree required, Bachelor’s Degree Preferred and a minimum of two or more years of related experience and/or training; or equivalent combination of education, training and experience. Must have experience in a medical device company. Skilled in MS Office suite and MS Windows, Adobe Acrobat helpful but not required.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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SPECIALIZED KNOWLEDGE AND SKILLS:
• Excellent organizational skills and extreme attention to detail.
• Ability to prioritize, multi-task and adapt to change.
• Ability to work effectively in a team environment and build strong working relationships.
• Ability to respond in a timely manner to inquiries from regulatory agencies.
• Word processing skills, including Microsoft Word, Excel and Power Point.
PHYSICAL ACTIVITIES:
This position will be working in an office environment, utilizing typical office equipment.
PHYSICAL DEMANDS:
The physical demands 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 this job, the employee is frequently required to sit, talk and hear. The employee is occasionally required to stand; walk; use hands, reach with arms; climb or balance; and stoop or kneel. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
Additional Information
Experience : 2+ more
Qualification : Bachelor’s Degree
Location : USA-CA-Carlsbad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th April, 2018
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