Senior Regulatory Affairs Specialist

Job Description:

POSITION SUMMARY

The Senior Regulatory Affairs Specialist provides strategic and technical guidance on domestic and potentially international regulatory requirements for new products and modifications. Prepare documentation for CE marking, international submissions, and FDA Pre-Sub/510(k) filings. Collaborate with cross-functional teams, manage multiple projects, and engage with regulatory authorities. Maintain current knowledge of regulations, support audits, and ensure accurate documentation and compliance.

RESPONSIBILITIES

This position is responsible for, but not limited to, the following:

• Provide strategic input and technical guidance on regulatory requirements for new technologies and product modifications, considering primarily domestic regulations

• Prepare technical documents to support PMA submissions and Pre-Sub and 510(k) submissions where applicable

• Participate in negotiations and interactions with regulatory authorities during the development and review process

• Support product registrations as needed

• Manage multiple projects and prioritize tasks on day-by-day basis to meet project schedules

• Interface with engineering, quality, clinical, marketing, and other functions as needed to fulfill responsibilities

• Maintain current regulatory knowledge of domestic and international regulations, guidelines, and standards

• Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements

• Participate in internal and external audits as needed

• Maintain Regulatory affairs documentation to support compliance with applicable regulatory requirements

• Perform other TransMedics tasks and duties as assigned/required.                                

MANAGEMENT RESPONSIBILITIES

This position manages the following positions on a daily basis.

• This position will not have management responsibilities.

PHYSICAL ATTRIBUTES

• General office environment where there is a significant amount of time at a desk, working on computers and reviewing documents. This requires the ability to sit for extended periods. They also may need to stand for meetings or when moving around the office.      

MINIMUM QUALIFICATIONS                                                      

• 8+ years regulatory experience in a regulated industry such as Medical Devices, Biotech or Pharma.

• Bachelor’s degree in science, engineering, regulatory affairs, or other technically related field; or equivalent combination of education and experience.

PREFERRED QUALIFICATIONS

• Excellent written, verbal communication and presentation skills.

• Experience in the preparation and submission of US and EU regulatory filings (MDD/MDR), including US Class II and III, and EU Class II and III devices.

• Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products.

• Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.

• Consults with others to understand the benefits and risks associated with decision alternatives before making decisions

TransMedics is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, national origin, marital status, age, disability or protected veteran status, or any other characteristic protected by law. We are committed to creating an inclusive environment for all employees.