Senior Associate, Regulatory Affairs- Device
Company: ICU Medical
Location: San Clemente
Posted on: June 1, 2021
Provides regulatory support and expertise associated with global
and US registration of device products (Consumables and Oncology
portfolios), 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
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
- 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
- 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
- Follows scientific arguments, identifies regulatory scientific
data needs and solves regulatory issues with alignment of
- 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
- Acts independently on all routine issues, makes judgment and
Education and Experience
- Bachelor's Degree preferred in pharmacy, biology, chemistry,
pharmacology, engineering or related subject.
- Master's Degree or P.H.D preferred
- RAC Certification preferred
- 7 years of experience in Medical Products Industry with a
minimum of 3 years of experience in Regulatory Affairs.
- Able to lead scientific arguments and apply analytical and
- Ability to effectively prioritize workload and multitask with
- Good interpersonal skills.
- Good oral and written communications skills.
- Demonstrated project management skills.
- Demonstrated critical thinking, contingency planning and
- Understanding of regulatory and business needs with ability to
establish direction and influence cross functional team
- Must be at least 18 years of age
Travel Requirements Typically requires travel 5-20% of the
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.
ICU Medical is an Affirmative Action and Equal Opportunity
Employer. All qualified applicants will receive consideration for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity, national origin, or protected veteran
status and will not be discriminated against on the basis of
Keywords: ICU Medical, San Clemente , Senior Associate, Regulatory Affairs- Device, Other , San Clemente, California
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