Specialist, Medical Writing

Make a meaningful difference to patients around the world. From design to production our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities and alongside diverse internal stakeholders your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients lives.

Dedicated to innovation our Surgical business unit is focused on identifying and solving critical unmet needs in cardiac understanding the challenges of open-heart surgery we partner with surgical teams to deliver modern technologies intended to enhance patients quality of life and expand their potential treatment opportunities. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

The Specialist Medical Writing Surgical-Regulatory Affairs will be responsible for supporting the development of clinical evaluation and post-market clinical follow-up documents under EU Medical Device Regulation (EU MDR).

How you will make an impact:

• Develop moderately complex medical writing documents/deliverables for assigned project(s)

• Serve as the primary contact negotiating deliverables timelines and resolving project-related issues in collaboration with cross-functional stakeholders

• Conduct literature searches and reviews including developing search strategy manage associated documentation and prepare literature summaries

• Provide input on other moderately complex cross-functional deliverables (e.g. risk management review IFUs SSCP) utilizing technical knowledge

• Identify recommend and assist in the implementation of continuous process improvements as it relates to medical writing

What you will need (Required):

• Bachelors Degree in related field 3 years of previous related experience in medical writing or equivalent work experience based on Edwards criteria

• Willingness to travel on-site once per quarter to meet with the larger team.

What else we look for (Preferred):

• Advanced Degree (Masters or PhD with experience working in a regulated industry or academia)

• Experience in scientific writing such as authoring publications manuscripts and research grants

• Familiarity with MEDDEV 2.7/1 and EU MDR for clinical evaluations

• Experience in preparing domestic and international product submissions

• Proven understanding of anatomy physiology and how to interpret data and summarize data in the cardiovascular space

• Proven expertise in Microsoft Office Suite including Word PowerPoint Access and Excel

• Excellent written and verbal communication skills and interpersonal relationship skills

• Strong problem-solving organizational analytical and critical thinking skills

• Ability to work independently ability to prioritize and manage multiple tasks simultaneously

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to work in a team environment including inter-departmental teams and representing the organization on specific projects

• Ability to build productive internal/external working relationships

Aligning our overall business objectives with performance we offer competitive salaries performance-based incentives and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

The base pay range for this position is $87000 - $123000 in tool (highly experienced).

The pay for the successful candidate will depend on various factors (e.g. geographic location qualifications education prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role as a condition of employment you will be required to submit proof that you have been vaccinated for COVID-19 unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.