Associate Regulatory Affairs Specialist
About The Position
This position is located in Lafayette, CO as part of the Acute Care & Monitoring (ACM) group. The Associate Regulatory Affairs Specialist (RAS) is responsible for collaborating, planning and executing regulatory activities related to the Nellcor™ pulse oximetry monitoring and digital solutions HealthCast™ remote patient monitoring product portfolios within the Acute Care and Monitoring operation unit. This is an ideal opportunity for someone early in their career who is excited to learn, collaborate, and build a strong foundation in regulatory affairs within a highly technical, fast-paced environment. As an Associate Regulatory Affairs Specialist, you’ll support regulatory strategy and execution for these complex, highly engineered products—partnering closely with R&D, Quality, Marketing, and other cross-functional teams throughout the product lifecycle. You’ll gain exposure to how products move from early design concepts through regulatory submission and commercialization, helping ensure compliance while enabling innovation.
Requirements
- Bachelor’s degree required
- Minimum of 2 years of relevant experience, or advanced degree with a minimum of 0 years of relevant experience.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
- U.S. work authorization
Nice To Haves
- Experience in medical device regulatory
- Strong experience with class I and II electrical and software-based devices including applicable standards.
- Strong knowledge of EU MDR, ISO 10993-1, ISO 13485, and ISO 14971 risk management principles.
- Experience with regulatory requirements for cybersecurity, AI, and communicating devices (interoperability).
- Proven experience authoring and leading 510(k) submissions and EU Change Notifications.
- Strong experience compiling MDR Technical Documentation.
- Experience communicating directly with regulators.
- Collaborative, solution-oriented performer focused on bringing value to stakeholders and the organization
- Proven ability to develop and execute on robust regulatory strategies.
- Strong experience reviewing promotional materials for US/EU markets.
Responsibilities
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Recommends strategies for earliest possible path to market.
- Supports submissions and inquiries for global markets.
- Collaborates closely with cross-functional partners such as R&D, clinical, operations, and marketing to establish regulatory value and ensure regulatory requirements and strategy are integrated into product development and lifecycle management.
- Reviews promotional material.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement
- Capital Accumulation Plan
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
