Senior Regulatory Affairs

Position Summary 

Provides regulatory support and expertise associated with global and US registration of medical device products, 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 registration packages for device products. Prepares registration packages 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. 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

• 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 letter.
• Follows scientific arguments, identifies regulatory scientific data needs and solves regulatory issues with alignment of regulatory management.
• 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.

Minimum Qualifications, Education & Experience 

• Must be at least 18 years of age
• High School Diploma required
• Bachelor’s degree from an accredited college in pharmacy, biology, chemistry, pharmacology, engineering or related subject or university is required
• Master’s Degree or P.H.D preferred
• RAC Certification preferred
• Seven plus years of experience in Medical Products Industry in Regulatory Affairs.
• Able to lead scientific arguments and apply analytical and logical reasonings.
• Ability to effectively prioritize workload and multitask with minimal supervision.
• Good interpersonal skills.
• Good oral and written communications skills.
• Demonstrated project management skills.
• Demonstrated critical thinking, contingency planning and negotiating skills.
• Understanding of regulatory and business needs with ability to establish direction and influence cross functional team members.

Work Environment

• This is largely a sedentary role. 
• This job operates in a professional office environment and routinely uses standard office equipment.
• Typically requires travel 5-20% of the time

Salary Range - $97,500 - $139,750

The salary range displayed represents the annual base salary we reasonably expect to pay for this role.  The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.

 ICU Medical provides a comprehensive total rewards package that includes:

• Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
• A wide range of benefit options at affordable rates
• Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement

 Additional information on health and welfare benefit offerings can be found at https://www.icumed.com/about-us/careers/investing-in-your-future/.