Sr. Regulatory Affairs Specialist

Bio Lab Holdings is a regenerative health company focused on providing innovative solutions that encourage the body to heal naturally. Our mission is to raise the standard of caring. Since its founding, Bio Lab Holdings has experienced explosive growth and is actively developing new technologies to innovate, improve customer experience, and expand its market share within the wound management space. We are seeking individuals who are passionate about making a difference in the work they do and will help support our company’s mission.

We are seeking an accomplished Regulatory Affairs leader with hands‑on regulatory experience to architect and drive regulatory strategy for our most complex products. This role is pivotal in shaping the regulatory landscape for our portfolio, navigating novel regulatory pathways, and ensuring timely market access. The successful candidate will operate as a subject matter expert and strategic partner to R&D and Executive Leadership, influencing early‑stage development and leading high‑stakes interactions with global health authorities.

Regulatory Strategy & Architecture

• Develop and execute global regulatory strategies for Class II and potentially combination products.
• Serve as the primary regulatory authority on product development teams, providing strategic input from concept through commercialization and post‑market.

Leadership of Complex Submissions

• Spearhead the preparation, authoring, and review of sophisticated regulatory submissions, demonstrating a proven track record with FDA Pre‑Submissions, 510(k), De Novo, and IDE, Knowledge of BLA submissions for combination products, and Knowledge of EU MDR Technical Documentation and interactions with Notified Bodies.

Agency Interaction & Negotiation

• Act as the primary company representative in all interactions with the FDA and other global health authorities.
• Lead meeting strategy, prepare briefing packages, and negotiate submission content and data requirements.

Clinical & Regulatory Integration

• Provide deep regulatory oversight and guidance to the Clinical Affairs team.
• Review and approve clinical study protocols, reports, and statistical analysis plans to ensure global regulatory compliance and acceptance.

Cross‑Functional Leadership

• Influence and guide R&D, Quality, Clinical, and Marketing leadership on regulatory requirements, risk management, and product development strategies.
• Mentor regulatory & quality staff and elevate the regulatory IQ across the organization.

Compliance & Lifecycle Management

• Maintain expert knowledge of evolving US and international regulations, standards, and guidance documents.
• Oversee regulatory aspects of post‑market surveillance and product lifecycle management.

* This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job. Other duties may be assigned.

• Bachelor’s degree in Engineering, Life Sciences, or a related technical field; advanced degree (MS, PhD, RAC) strongly desired.
• Minimum of 5‑7+ years of progressive Regulatory Affairs experience within the medical device industry, with a focus on Class II devices.
• Demonstrated expert‑level mastery in the preparation and successful clearance/approval of FDA 510(k) and at least one of the following:
  De Novo, IDE, and or BLA.
• Proven experience as the primary lead in formal FDA interactions (e.g., Pre‑Sub, Panel Meetings).
• Extensive background collaborating with Clinical Affairs on the development of clinical study protocols and management of IRB/IEC submissions.
• Superior written and verbal communication skills, with a demonstrated ability to articulate complex regulatory strategies to executive leadership and influence decision‑making.

• Direct experience with diverse device technologies such as optical/imaging systems or energy‑based applications.
• Significant experience with Class II devices, combination products and an understanding of the nuances of BLA submissions are a plus.
• Proven success in preparing EU MDR Technical Documentation and interfacing with Notified Bodies.
• Experi…