Senior Director Regulatory Affairs and Quality Assurance

Senior Director Regulatory Affairs and Quality Assurance Senior Director, Quality Assurance & Regulatory Affairs

Function:

Regulatory Affairs and Quality Assurance

Industry:

Medical Devices | Vision Care

About Our Client

Our client is a global leader in Class III medical device manufacturing of

advanced orthokeratology and ophthalmic

products. With U.S. headquarters in

Virginia

and offices in

Shanghai and Beijing , our client is helping lead the global charge in a recession proof industry.

Their products are

FDA-approved ,

CE-marked , and

cleared in numerous international markets

— manufactured right here in the U.S.A.

About the Role The

Senior Director, Quality Assurance & Regulatory Affairs (QARA)

will lead global quality and regulatory strategy, ensuring our products meet all applicable

U.S. and international standards . This individual will serve as a key

regulatory authority and quality expert

— building scalable systems, guiding cross‑functional teams, and engaging with global regulatory bodies to advance innovation and compliance.

You’ll work closely with executive leadership, R&D, engineering, and manufacturing to strengthen our quality systems, streamline regulatory pathways, and position Euclid for continued global growth.

Key Responsibilities

Lead

regulatory strategy and execution

for all global markets, including FDA, EU MDR, UK MDR, and other regulatory authorities.

Oversee

Quality Assurance programs

to ensure product compliance, audit readiness, and lifecycle excellence.

Serve as

primary liaison

with regulatory agencies, representing our client during inspections, audits, and technical reviews.

Develop and maintain

best‑in‑class quality systems , driving continuous improvement across design, manufacturing, and post‑market processes.

Direct and mentor a

high‑performing QARA team , fostering technical expertise and leadership capabilities.

Provide

strategic input

on new product development, submissions, labeling, and promotional compliance.

Lead and author

regulatory submissions

(e.g., PMAs, 510(k), IDEs, Technical Files) ensuring they are prepared and filed accurately and efficiently.

Oversee

post‑market surveillance , complaint handling, vigilance reporting, and recall management as needed.

Qualifications

Bachelor’s degree

in Life Sciences, Engineering, or a related field (MS preferred).

15+ years

of regulatory affairs and quality leadership experience in the

medical device industry .

Proven success preparing and obtaining

approvals for Class III medical devices

(implantables) in the U.S. and EU.

In-depth knowledge of

FDA QSR, EU MDR, and international regulatory frameworks .

Demonstrated leadership of cross‑functional and global teams (8+ years management experience).

Strong communication, negotiation, and presentation skills — including experience interfacing with the

FDA and other regulatory bodies .

Vision care or optical device experience a

plus .

Why Apply

Lead a talented global team within a

fast‑growing medical device company .

Collaborate across innovation, manufacturing, and global markets.

Competitive compensation and benefits package.

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