Senior Regulatory Affairs Specialist: SaMD & MedTech

OrganOx; Boston (MA); Hybrid; USD 120,000 - 160,000; Full time

Benefits offered by this job

Health, dental, vision coverage

401(k) retirement plan

Paid time off & holidays

Onsite wellness facility

Job summary

OrganOx is seeking a Senior Regulatory Affairs Specialist to prepare regulatory submissions (FDA Q-Submissions, INDs, IDEs and PMAs) for North America, and to assist in implementing the company’s quality goals and objectives.

The role reports to the Director, Regulatory Affairs, Software and Innovation, and collaborates with cross-functional teams. It may require up to 5% travel domestically or internationally, with a flexible remote or hybrid on-site work arrangement.

Qualifications

• Working knowledge of FDA processes for medical device compliance.
• Experience with SaMD, SiMD, Cybersecurity and electromechanical products.
• Experience with Class II and Class III devices.
• Ability to write regulatory strategies and submissions.
• Good GMP compliance understanding in Quality Control.
• Experience collaborating with Manufacturing, Quality, R&D, Clinical and Marketing.
• MS Office proficiency.
• Excellent verbal and technical writing skills.
• Ability to work independently.

Responsibilities

• Provide regulatory affairs support for Digital Health, Software, Cybersecurity, and Electromechanical devices.
• Support pre-market and post-market regulatory activities for assigned projects.
• Collaborate with cross-functional teams to provide regulatory support.
• Prepare regulatory submissions (IDE; IDE Supplements; PMA; PMA Supplements, etc.) for submission to the FDA and Health Canada.
• Interface with the FDA and Health Canada on assigned projects.
• Respond to FDA and Health Canada requests for additional information.
• Keep abreast of changes to US and Canada regulatory requirements and International Standards related to OrganOx products and processes.
• Formally communicate regulatory initiatives or changes in the applicable medical device law with company personnel, customers, subcontractors, regulatory agency representatives, and third-party organizations.
• Perform regulatory change assessments as required.
• Reviewing applicable regulatory guidance and standards for assigned projects to ensure compliance with regulations and determining regulatory impact.
• Prepare visualizations and conclusions for presentation to upper management.
• Working with key stakeholders in relation to Regulatory topics.
• Adhere to the letter and spirit of OrganOx’s Code of Conduct and all other company policies.

Skills

FDA regulatory processes

SaMD/SiMD/Cybersecurity

Class II/III devices

Regulatory strategy writing

GMP/Quality understanding

Cross-functional collaboration

MS Office proficiency

Verbal & technical writing

Independent work

Education

Bachelor’s degree in engineering or life sciences

Regulatory Affairs Certification (RAC) (Optional)

Tools

MS Office

Job description

OrganOx is seeking a Senior Regulatory Affairs Specialist to prepare regulatory submissions (FDA Q-Submissions, INDs, IDEs and PMAs) for North America, and to assist in implementing the company’s quality goals and objectives.

The role reports to the Director, Regulatory Affairs, Software and Innovation, and collaborates with cross-functional teams. It may require up to 5% travel domestically or internationally, with a flexible remote or hybrid on-site work arrangement.