Prin Regulatory Affairs Spec
About The Position
This position is located in Lafayette, CO and supports the Acute Care & Monitoring (ACM) operating unit. The Principal Regulatory Affairs Specialist (Pr. RAS) provides regulatory leadership and strategic direction for the Core Respiratory product portfolio within ACM. This role is responsible for collaborating with cross-functional partners to develop, plan, and execute global regulatory strategies across early development, commercialization, lifecycle management, and business transition activities. This position is suited for a high-performing individual contributor who operates with a high degree of autonomy on moderately to highly complex programs. With limited supervision, the Pr. RAS sets objectives aligned with broader business and portfolio goals, drives regulatory strategy, and contributes to critical project and business milestones. The role requires strong awareness of cross-functional and organizational initiatives and the ability to assess regulatory impact on business decisions. The Pr. RAS regularly communicates with internal stakeholders to provide strategic input, share updates, and support informed decision-making. Serving as a regulatory subject matter expert and individually contributing leader, this role acts as a role model within the organization and may mentor or provide guidance to junior regulatory professionals or support staff as needed. Position requires to be onsite 4 days per week in our Lafayette, CO location.
Requirements
- Bachelor’s degree required
- Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.
Nice To Haves
- Extensive experience in medical device regulatory affairs.
- Strong hands-on experience with U.S. Class I and II medical devices, including applicable regulatory requirements and consensus standards.
- In-depth knowledge of EU MDR, ISO 13485, ISO 14971 risk management principles, and ISO 10993-1.
- Proven experience authoring and leading U.S. regulatory submissions (e.g., 510(k), PMA) and EU Technical Documentation and change notifications.
- Demonstrated expertise in compiling and maintaining EU MDR Technical Documentation.
- Experience interacting directly with regulatory authorities in the U.S., EU, and/or other global markets.
- Strong experience reviewing and advising on advertising and promotional materials for U.S. and EU markets.
- Demonstrated ability to develop and execute regulatory strategies that support business and product objectives.
- Collaborative, solution-oriented professional with a strong focus on delivering value to stakeholders and the organization.
- 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.
Responsibilities
- Lead and execute global regulatory strategies across the product lifecycle, including early development and business wind-down activities.
- Provide regulatory strategy input for early-stage development, including pathway assessment, classification, and data requirements.
- Serve as a strategic partner to R&D, marketing, clinical, operations, and leadership to integrate regulatory considerations into product and business decisions.
- Act as regulatory lead for advertising and promotional material review, providing strategic guidance on claims, risk communication, and compliant promotional approaches.
- Lead or oversee preparation of U.S. and EU regulatory submissions, and support submissions for global markets.
- Recommend and guide changes to labeling, manufacturing, marketing, and clinical activities to ensure compliance and support business objectives.
- Monitor and interpret global regulatory requirements and changes, proactively communicating risks and opportunities to stakeholders.
- Support and lead regulatory agency interactions, audits, inspections, and CAPA activities, as appropriate.
- Develop and deliver regulatory training; mentor junior regulatory staff.
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 (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
