- Minimum BS in life sciences including engineering (mechanical, biomedical and/or systems) and natural/physical science (chemistry, biology, and biochemistry)
- 12 plus years of relevant work experience, specifically in the regulated pharma/medical space within medical device or combination products with 5-7 plus years of leadership experience.
- Extensive knowledge of applicable medical device regulations (21CFR820, 21CFR Part 4, EU MDR, ISO 13485)
- Experience with Design Controls / CAPA / Purchasing Controls as it related to 21CFR820.
- Risk Management experience (ISO 1497124971, ICH Q9)
- Expert knowledge and a comprehensive understanding of device technologies preferably infusion pumps/sterile administration sets and process (e.g., injection molding, automated assembly)
- Effective communication skills and working knowledge of device development and commercialization, product approval, and/or regulatory inspection experience with medical devices.
- Must be able to work independently within a cross functional framework and will involve detailed technical writing and review.
- A high degree of creative thinking, resourcefulness, and networking will be required to coordinate projects or solve problems.
- Ability to work in a matrix organization and effective written and oral communicator.
- Possesses knowledge and a skill set to operate within an environment that requires a high degree of urgency, positive interpersonal skills, and ability to manage multiple complex tasks simultaneously.
- Capable of analyzing data facts and informed opinion to direct the development of effective action plans as well as the ability to problem solve without the benefit of precedent.
- Ability to understand and overcome cultural and language barriers to provide effective strategies and successful outcomes.
- Between 30 to 50% travel both domestically and internationally.
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.
MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection. In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.
The salary range for this position is $155,000 - $264,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.
This position is eligible to participate in our annual Short-Term Incentive (STI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.
This position is eligible to participate in our Long-Term Incentive (LTI) program. Specific information about the plan including eligibility rules and target, will be furnished upon hire.