Associate II, Regulatory Affairs

Job Description

Position Summary

Provide regulatory support and expertise associated with US and global submission requirements, including analysis of the requirements and tracking of deliverables. With oversight, supports execution of global regulatory strategies and assists in creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management to enable product approval and issuance of EC certificates, FDA or other international certificates/permits/approvals. Ensure that key strategic new products are developed in line with the global registration requirements.

Essential Duties & Responsibilities

• Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations.
• Plans and organizes registration packages for device products. Prepares registration packages in line with regional regulatory requirements and guidelines.
• With oversight, understand and respond to regulatory agencies or notified body correspondences.
• 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.
• 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.
• Understand global regulations and assure regulatory compliance, minimizing development costs and cycles.
• 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
• 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.
• Reviews regulatory commitments, strategy decisions, meeting strategies with regulatory authorities and changes to resource allocations with manager prior to execution.
• Work on special projects as assigned
  
  

Knowledge & Skills

• Proven strong understanding of FDA, EU and worldwide submission requirements.
• Proven strong record of preparing regulatory submissions and obtaining approvals.
• Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
• Understand global regulations and assure regulatory compliance, minimizing development costs and cycles.
• Prepare and maintain regulatory strategy with supervision.
• Advanced experience with assembling global dossiers
• Two to four years of medical device industry experience with regulatory affairs with direct FDA and global submission experience and authoring CE technical documentation.
• Strong understanding of 21 CFR 820 and ISO 13485:2016 requirements.
• Well-developed experience working directly with regulatory agencies. Sound knowledge of applicable portions of agency regulations and applicable guidance documents.
• Advanced ability to critically assess scientific arguments.
• Excellent oral and written communication skills.
• Strong problem-solving skills
• Excellent interpersonal skills.
• Well-developed negotiating skills. Strong understanding of business needs.
  
  

Minimum Qualifications, Education & Experience

• Bachelor’s Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• RAC Certification preferred
• A minimum of two years of experience in Medical Products Industry in Regulatory Affairs.
• Able to assess 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 regulatory and business needs with ability to engage cross functional team members.
• 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.
• Work may be performed in a home office using standard office equipment
• While performing the duties of this job, the employee may be required to sit, stand and walk for long periods of time.
• Typically requires travel less than 5% of the time
  
  

Salary Range - $63,750 - $91,375

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/ .

About Us

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.
  
  

ICU Medical EEO Statement

ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [email protected]. We are committed to providing equal access and opportunities for all candidates.

ICU Medical EEO Policy Statement

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