Senior Director of Medical Safety and Compliance

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

The Senior Director of Medical Safety and Compliance will lead the Medical Safety & Compliance team, ensuring that Medical & Scientific Affairs are strategically positioned to provide timely medical and clinical consultation and review for pre- and post-market risk assessments, medical review, and adverse event reporting. This role is crucial in maintaining high standards of medical safety, compliance, and regulatory adherence at Beckman Coulter Diagnostics. Additionally, the role involves significant cross-functional interactions, coordination with quality and regulatory teams, oversight of external safety boards as needed, and a focus on team training, development, and leadership.

This position is part of the Medical and Scientific Affairs team located in US reporting to the Chief Medical Officer and will be a fully remote position. The Medical and Scientific Affairs team strives to provide medical and scientific expertise that drives innovation and clinical adoption of BecDx solutions that improve patient care.

If you thrive in a role utilizing your clinical/medical knowledge helping patients and want to work to build a world-class Medical Affairs organization—read on!

In this role, you will have the opportunity to:

• Lead and manage the Medical Safety & Compliance team, fostering a culture of excellence and continuous improvement ensuring timely and accurate medical and clinical consultation and review for pre/post-market risk assessments, medical review, and reporting of adverse events.
• Develop and maintain structures, process and procedure for effective medical risk assessments and all other medical safety activities
• Manage cross-functional interactions to ensure integration of medical safety and compliance strategies with other departments (quality, regulatory, R&D, and others)
• Support pre/post-market activities including design specifications, regulatory submissions, and review of marketing and promotional materials.
• Provide medical/technical input to the strategic planning process for clinical innovation/new product development.
• Represent the Company in discussions with regulatory agencies about clinical/medical matters relating to existing and future products. 
• Lead and oversee external expert advisory boards to ensure comprehensive safety and compliance oversight.

The essential requirements of the job include:

• Physician (MD or equivalent)
• 6+ years of clinical experience
• 5+years leading Medical teams
• Experience with Regulatory Authority presentations is preferred, and strong collaborator.
• Bachelor’s degree with 20+ years experience OR Masters/Doctoral degree with 18+ years exp.

It would be a plus if you also possess previous experience in:

• Experience in clinical laboratory operations and/or in vitro diagnostics industries desirable.
• Board Certification (if US) preferred; Medical specialization preferred
• Experience or training in adverse event reporting, risk assessments, and/or regulatory submissions desirable.

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

• The salary range for this role is $300K - $330K. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modif