Provides regulatory support and expertise associated with global and US registration of device products (infusion pump consumables, catheters, introducers), including in-depth analysis of the requirements and tracking of deliverables. With oversight, supports creation of global regulatory strategies and assists in execution including creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management.
Essential Duties & Responsibilities
Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations.
Plans and organizes regulatory documentation for device products. Prepares regulatory submissions (510(k), EU technical files) in line with local regulatory requirements and guidelines.
With oversight, serves as a liaison with regulatory agencies pertaining to assigned products. Assists in the preparation of agency meeting packages and strategies for agency meetings.
Evaluates manufacturing and labeling changes for regulatory impact with guidance. Accurately describes these changes for ease of regulatory agency review.
Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team.
Knowledge, Skills & Qualifications
Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission.
Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
Interpret global regulations and assure regulatory compliance, minimizing development costs and cycles.
Define and negotiate regulatory strategy with supervision.
Exercise good judgment within policy and regulations.
Responsible for tracking and completion of assigned registration activities. Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters.
Follows scientific arguments, identifies regulatory scientific data needs and with supervision solves regulatory issues.
Presents scientific data effectively orally and in writing in a logical and persuasive manner.
Provides daily regulatory support to new product development teams and commercial support with guidance.
Participates in preparing regulatory strategies. Reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution.
Acts independently on all routine issues, makes judgment and executes
Education and Experience
Bachelor's degree from an accredited college or university is required
Degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
RAC Certification Preferred
Three to five years of experience in Regulatory Affairs, Research, Development or related area.
Must be at least 18 years of age
Must pass pre-employment drug screen and background check
Able to follow scientific arguments
Good interpersonal skills
Good oral and written communications skills
Developing negotiating skills
Developing understanding of business needs
Physical Requirements and Work Environment
This is largely a sedentary role.
This job operates in a professional office environment and routinely uses standard office equipment
Work is performed in a clean room environment
While performing the duties of this job, the employee may be required to sit or stand for long periods of time; depending on the machine they are operating
Operator is required to use computer or touch screen to enter work order data
Must be able to occasionally move and lift objects of up to 25 lbs
We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.