Since 1858, Dohmen has been driven by the desire to get safe and effective treatments and cures to the people that need them most. As entrepreneurs, we’ve looked for new and better ways of doing this year after year. Today, as Dohmen Life Science Services, we bring the industry’s most comprehensive service array to Medical Device, Biotech and Pharmaceutical entrepreneurs, helping them get farther faster and keeping them focused on innovations that improve lives.
Our behavior is guided by five simple values –
Caring: We are empathetic and respectful. We ask “how can I help you”
Committed: We are dedicated and persistent. We ask “how can I make it happen”
Creative: We are inventive and imaginative. We ask “how can I do it better”
Collaborative: We are cooperative and share our knowledge. We ask “how can we achieve success”
Courageous: We’re willing to risk failure over inaction. We ask “how can I challenge myself”
This perspective defines us. How we act, how we do business, how we work with our clients and how we work with each other. They are essence of what makes us successful. They are what set us apart.
The most important aspect of the position of the VP of Regulatory Affairs Compliance will be having the responsibility for managing the regulatory compliance consulting service line and aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies. The major focus of this team is auditing/conducting gap assessments/supplier qualification and oversight and leading a team of qualified auditors. This person will assign work to the regulatory compliance consulting resources and participate in business development for regulatory compliance. This person will also function as a direct contact with regulatory authorities for Denver site audits and audits of clients and will to facilitate the prompt review and approval of submissions related to audits, audit responses. This person will develop appropriate responses to FDA 483s and Warning Letters. This position is a member of DLSS’ Executive Management Team (EMT) as well as a member of the Management Review Team and will serve as the Management Representative for ISO/EN Certifications.
POSITION SUCCESS FACTORS:
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED: