My client is a global medical device company that manufactures and sells medical devices. Their aim is to improve medical discovery and diagnostics. It is a exciting time for the company as they are looking to onboard a Regulatory Affairs Specialist to their dynamic team. This is a full time permanent remote position.
The role
The Associate Director, Regulatory Affairs (RA) will be an integral part of the SCC platform. They will be developing and executing sound regulatory strategies for a range of complex programs, with emphasis on electromechanical, software, and connected care products. They will be responsible for building a team of RA professionals to support the SCC platform, providing ongoing developmental opportunities, supporting team building activities, and promoting a healthy work/life balance. They will oversee cross-platform collaboration in obtaining approvals/clearances for bringing new products to market, prioritization of workload, monitoring of performance through regular updates and metrics, interactions with regulatory agencies/notified bodies, and providing guidance on complex regulatory matters.
Main Responsibilities
- Recruit, hire, train, lead, develop and motivate the SCC RA team.
- Develop the talent of direct reports through performance management, guidance, and the identification of development opportunities.
- Build a strong, motivated team by encouraging growth, engagement, team building, and a healthy work/life balance.
- Create and implement complex regulatory strategies and plans for bringing new SCC products to market.
- Plan and run regulatory support for key projects to ensure resources are provided as needed and report metrics to upper management.
- Coordinate and prepare regulatory submissions, including classification requests, pre-submission meetings, 510(k) premarket notifications, De Novo requests, and EU MDR Technical Documentation.
- Represent the business in interactions with regulatory agencies regarding regulatory pathways for SCC products, premarket submission requirements, strategies, labeling claims, etc.
- Provide a high level of regulatory support to SCC core teams in the development of regulatory strategies, review and approval of project documentation, and active participation at team meetings.
- Remain current on regulations and standards relevant to electromechanical, software, and connected care devices.
- Ensure new regulations or changes to existing regulations are communicated throughout the organization through company policies, procedures, and training.
Requirements
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything
- BA/BS in Engineering/Scientific field or related. Advanced degree desired.
- RAC certification desired.
- 8-10 yrs. experience within medical device industry in a regulatory and/or quality function.
- 4-6 yrs. leadership/management experience.
- Extensive knowledge of medical device regulations with an emphasis on FDA and EU MDR. Experience with additional international regulations preferred.
- Extensive experience with obtaining regulatory approvals/clearances for electromechanical, software, and connected care devices.
- Extensive 510(k), IDE, PMA, EU MDR Technical File/Design Dossier preparation, review, and submission experience.
- Extensive experience interacting directly with regulatory authorities/notified bodies.
- Demonstrated ability to apply in-depth knowledge of relevant regulations and standards in the development of compliant, least burdensome regulatory pathways.
- Demonstrated ability to attract and develop versatile employees, encourage a strong team dynamic, and promote a healthy work/life balance.
- Demonstrated ability to oversee prioritization of workload and address resource issues as they arise.
- Demonstrated ability to think strategically and work effectively in a team-based, matrix environment.
- Demonstrated ability to work effectively on complex projects with ambiguity and/or rapid change.
- Demonstrated excellent interpersonal, written, oral, communication, organizational and planning skills
- Demonstrated knowledge of MS office suite (Word, PowerPoint, Excel and Access)
- Excellent understanding of scientific principles and ability to comprehend and explain product related technical documentation.
Connect
If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.
Medella Life
As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything