- Bachelor’s degree in engineering, science or a related area required. Experience in drug delivery or combination devices desired.
- A minimum of 5 years of experience in Class II or III medical device or a related industry with experience in Regulatory Affairs operations comprising of US, EU submissions preparations. International submissions experience is desirable.
- Experience and knowledge of the relevant current requirements for medical device or combination product submissions to US FDA and prior interaction or exposure with other key regulatory authorities (e.g. EU Notified body, competent authorities, APAC regulatory agencies).
- Strong computer skills; experience with the creation and revision of documents using software programs such as Microsoft Word and Adobe Acrobat Pro.
- Excellent oral and written communication and interpersonal skills.
- Highly organized and attentive to detail, with ability to understand and organize complex documentation.
- Ability to consistently meet tight timelines and deadlines. Ability to interact effectively with team members and prioritize multiple projects.
- Technical proficiency, effective problem solving and critical thinking skills.
- Ability to work in a team environment
Disclaimer
INOVIO Pharmaceuticals, Inc. is committed to a policy of equal employment opportunity. In keeping with our policy, INOVIO will recruit, hire, train and promote into all job titles the most qualified individuals, without regard to race, color, creed, gender, gender identity and expression, religion, marital status, registered domestic partner status, age, national origin or ancestry, military or veteran status, physical or mental disability, medical condition including genetic characteristics, sexual orientation, or any other consideration made unlawful by federal, state, or local laws.
A current US work authorization is required. The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. INOVIO offers an attractive benefits package and is an equal opportunity employer.
Important notice to employment businesses/agencies
INOVIO does not accept referrals from employment agencies unless written authorization from the INOVIO Human Resources department has been provided. In the absence of written authorization, any actions undertaken by employment agencies shall be deemed to have been performed without our consent and therefore INOVIO will not be liable for any fees arising from employment agency referrals in respect to current or future position vacancies at INOVIO.
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