Senior Medical Device Regulatory Affairs Specialist

OrganOx Limited; Alabama; Hybrid; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health, dental, vision benefits

401(k) retirement plan with company匹配

Paid time off and holidays

Onsite wellness facility

Job summary

OrganOx Limited in the United States (hybrid in Madison, NJ) seeks a Senior Regulatory Affairs Specialist to lead regulatory activities across the product lifecycle for assigned devices. You will develop regulatory strategies, assess changes for regulatory impact, and prepare submissions for the U.S.

market and other jurisdictions. The role requires deep experience in regulatory affairs within the medical device sector, US Class III device familiarity, and ability to travel up to 5%.

Qualifications

• Minimum of a Bachelor’s degree in technical discipline (Engineering or Life Sciences).
• Minimum of 5 years of regulatory affairs experience within the medical device or similar industry.
• Demonstrated experience with successful submissions in key markets such as U.S. and EU.
• Ability to travel 5% domestically and/or internationally.

Responsibilities

• Lead and support pre-/post-market regulatory activities for devices and product changes.
• Perform regulatory impact assessments for design, labeling, packaging, supplier, and manufacturing changes.
• Prepare, compile, and coordinate regulatory submissions and change notifications (PMAs, PMA supplements, amendments, annual reports, etc.).
• Support regulatory authority interactions by drafting correspondence and coordinating responses.
• Partner with project teams to define regulatory requirements and ensure alignment with requirements.
• Review documentation and evidence supporting regulatory activities (verification/validation, risk management).
• Contribute to departmental process improvements and regulatory intelligence activities.
• Provide training and support to other department members.
• Adhere to OrganOx's Code of Conduct and company policies.

Skills

Regulatory strategy

Regulatory submissions

Technical writing

Cross-functional collaboration

Regulatory intelligence

Education

Bachelor’s degree in Engineering or Life Sciences

Job description

OrganOx Limited in the United States (hybrid in Madison, NJ) seeks a Senior Regulatory Affairs Specialist to lead regulatory activities across the product lifecycle for assigned devices. You will develop regulatory strategies, assess changes for regulatory impact, and prepare submissions for the U.S.

market and other jurisdictions. The role requires deep experience in regulatory affairs within the medical device sector, US Class III device familiarity, and ability to travel up to 5%.