Prin Regulatory Affairs Specialist

IntePros; Lafayette (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

A medical device company is seeking a Principal Regulatory Affairs Specialist to oversee regulatory activities for the INVOS™ Cerebral/Somatic Oximetry product line. The role requires at least 7 years of regulatory experience within medical devices. The successful candidate will work collaboratively with various teams to ensure compliance and will direct regulatory submissions including 510(k)s. Ideal applicants must demonstrate strong knowledge of EU MDR and FDA processes, and be capable of mentoring junior staff.

Qualifications

• Minimum 7 years of relevant experience required.
• Advanced degree requires 5 years of relevant experience.

Responsibilities

• Lead regulatory submissions for the INVOS™ Cerebral/Somatic Oximetry product.
• Collaborate with cross-functional teams.
• Mentor junior staff as needed.

Skills

Experience in medical device regulatory

Proven ability to develop regulatory strategies

Experience with FDA submissions

Knowledge of EU MDR

Strong verbal communication

Education

University Degree

Job description

Technical Skills

Collaboration, solution-oriented performer focused on bringing value to stakeholders and the organization.

Must Have

• Experience in medical device regulatory
• Proven ability to develop and execute robust regulatory strategies
• Proven experience authoring and leading 510(k) submissions and EU Change Notifications.
• Strong experience compiling MDR Technical Documentation
• Strong experience reviewing promotional materials for US/EU markets
• Strong knowledge of EU MDR, ISO 10993-1, ISO 13485, and ISO 14971 risk management principles.

Nice To Have

• Experience communicating directly with regulators
• Experience with FDA presubmissions
• Experience with regulatory requirements for cybersecurity and communicating devices (interoperability).
• Strong experience with class I and II electrical and software-based devices including applicable standards.

HM's Top Needs

• Strong experience with 510(k)s and presubs, and experience communicating directly with FDA
• Strong experience with medical devices that have integrated software with clinical based supporting evidence
• Strong experience reviewing promotional materials

The Job

The Principal Regulatory Affairs Specialist (Pr. RAS) is responsible for collaborating, planning and executing regulatory activities related to the INVOS™ (BIS™) Cerebral/Somatic Oximetry product portfolio within the Acute Care and Monitoring operation unit. This role is fit for an established, productive individual contributor and leader who works independently on moderately to highly complex projects or programs with limited general supervision. In the position, you will set objectives for your own work to align with broader project goals and actively contribute to key milestones. You will also participate in cross-functional activities, requiring awareness of wider organizational issues.

You will recommend and own improvements to systems and processes to enhance effectiveness and regularly communicate with internal stakeholders to share updates, gather input, and support decision-making. You will function as a subject matter expert within the organization and as an individual contributing leader. As such, you serve as a role model and may also guide entry-level professionals or support staff, eventually offering direction and assistance when needed.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads and compiles all materials required for US and EU submissions and tenders, including 510(k) submissions, NB sampling, and EU MDR Technical Documentation.
• Supports submissions and inquiries for global market.
• 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.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Reviews promotional material.
• Monitors, updates, and improves project tracking and US/EU distribution control systems.
• Proactively monitor and interpret evolving global regulatory requirements and communicate potential impact to stakeholders.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible path to market.
• Support internal and external audits/inspections, including serving as a functional lead.
• Develop and deliver training on regulatory requirements and changes to cross-functional teams.
• Mentor junior regulatory staff or provide onboarding support.
• Participate in CAPA investigations when regulatory issues are identified.

Qualifications

Requires a University Degree and minimum 7 years of relevant experience, or an advanced degree with a minimum of 5 years of relevant experience.