Prin Regulatory Affairs Specialist

Prin Regulatory Affairs Specialist


TECHNICAL SKILLS

Must Have
Collaborative, solution-oriented performer focused on bringing value to stakeholders and the organization
Experience in medical device regulatory
Proven ability to develop and execute on 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:

1. Strong experience with 510(k)s and presubs, and experience communicating directly with FDA
2. Strong experience with medical devices that have integrated software with clinical based supporting evidence
3. 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 individually 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.
Requires a University Degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

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