Medical Director – Medical Devices (100% remote)

Cactizens make an impact. We seek professionals who see things differently; who find opportunity where others don't; and who look within themselves and know that with the right support and team, they can impact the world.

CACTUS is currently looking to add self-motivated, entrepreneurial members to its medical

communications team. This is an opportunity to grow your career and make an impact in the healthcare space as well as on the lives of countless healthcare professionals and patients around the world.

Roles and Responsibilities

• Function as head of content and subject matter expert on all matters related to medical devices,
• Expertise in clinical evaluation (specifically reviewing and/or writing clinical evaluation reports
• and all regulatory requirements under the new EU MDR), regulatory writing/consulting for
• medical devices in the EU and US (expertise beyond those two regions is a plus),
• Recruit, lead, and develop talent; train new writers on creation of regulatory/clinical
• deliverables for medical devices (e.g., CEP/CER, PMS plan/PMSR/PSUR, PMCF plan/evaluation
• reports, Technical Files, CSRs, 510(k)s, IVD documents, regulatory pathways/research)
• Help lead development of new services and new regions for growing medical device team in order to expand business reach and capabilities
• Guide and closely review the work performed by both the in-house team of scientific writers
• and freelance contributors; responsible for continuous skill-building
• Accountable for overall content strategy, ensuring medical scientific rigor and delivery of high quality documents to the client
• Participate in client pitches and in organic and new business development activities
• Participate in thought leadership activities, including white paper development, facilitating
• advisory board/panel meetings, speaking at industry conferences, etc.

What’s in it for you?

1. Global exposure: We work with the top 10 pharmaceutical and medical device companies across

the globe.

2. Culture & Team: We never stop recruiting the best people because without an amazing team

nothing is possible. People at CACTUS are awesome to work with, driven, smart and know how

to get things done.

3. Learn & Grow: Our goal is to keep you as long possible and help you build a career with us. We

do this by creating an environment where you will grow both personally and professionally.

4. Satisfaction & Recognition: With some of the biggest names across the globe as existing clients,

doors will open and conversations will flow. You will see the results of your efforts translate into

maximum impact. With a competitive salary and our recognition programs, you will be

rewarded for your success.

So how do we know that’s you? You have the personality and the experience;

• RAC or 8 – 10 years in Medical Device regulatory service or manufacturing industry
• Meet the requirements to act as signatory and medical director for Clinical Evaluation Report
• (CER) team
• MD or PhD in a relevant field, with 8-10 years of overall experience in clinical development/regulatory affairs for medical devices
• Domain expertise in clinical evaluation and post-market surveillance/PMCF and thorough understanding of EU MDR and related guidelines (e.g., MedDEV 2.7/1 Rev 4, MDCG) and harmonized standards (e.g., ISO 14971)
• 4-5 years of experience in the development of CERs for all classes of medical devices in a CRO or medical device company setting; experience collaborating with device manufacturer cross functional review teams
• Experience working with Notified Bodies & FDA (e.g., with auditors or engagement for pre submission activities/remediation or response activities is highly desirable)
• Ability to develop thoughtful analysis and compelling narrative within technical documentation
• Proactive, accountable, critical thinker with high integrity
• Strong leadership ability and people management experience
• Willing to travel to client meetings or to office locations globally when/if needed.