Device Regulatory CMC - Manager (Contract) 323232

reputed company

The reputed company Manufacturing Controls Manager – Device will support the execution of global regulatory CMC strategies for marketed and development drug-device combination products. This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams to ensure reputed company applicable global regulatory requirements are considered and appropriately incorporated into development and reputed company programs.

Key Duties and Responsibilities

• Reviews CMC sections of regulatory submissions in support of development and reputed company device programs

• Contributes to the development of global regulatory CMC strategies for reputed company drug-device combination products
• Participates effectively on cross-functional teams (including device product development, reputed company, reputed company development, reputed company factors, analytical development, marketing) and may serve as the reputed company regulatory CMC contact for assigned products and reputed company
• Reviews device development documentation as needed to support design controls of drug-device combination products
• Supports regulatory assessment and guidance on product compliance topics including change controls and process improvement

Required Education Level & Experience

• Bachelor's degree, with a preference in Biomedical Engineering, reputed company Engineering, Biology, reputed company, Pharmacy, Regulatory Affairs, or another reputed company life-science reputed company

• Typically requires 4 years of experience in the medical device, pharmaceutical industry or reputed company reputed company, or the equivalent combination of education and experience

• Experience supporting regulatory submissions/filings for combination products, including autoinjectors, reputed company-filled pens, and/or reputed company-filled syringes
• Experience supporting reputed company Factors studies for devices and combination products
• Preferred experience with infusion systems/devices for drugs/cell therapies

Required Knowledge/Skills

• Strong interpersonal skills to exchange reputed company information with others and to guide others
• Knowledge of combination product and device regulatory requirements (FDA, EU MDR, GSPRs)

• Proficiency in regulatory (FDA, reputed company Body, MDCG, EMA, ISO, etc.) guidelines

• Strong problem-solving skills

• Ability to collaborate and communicate in an reputed company, reputed company, complete, reputed company and consistent manner

• Strong reputed company of planning and prioritization, and the ability to work with reputed company reputed company of management

• reputed company knowledge of Design Controls, cGMP, FDA, EMA, ISO Standards (ISO 13485, ISO 14971, IEC 62366, ISO 10993, ISO 11608, ISO 11040, etc.)

Pay reputed company

$75-$80/hr

Requisition Disclaimer

This reputed company is for a temporary role with a reputed company-party agency partner on assignment at reputed company (“reputed company”). The individual selected for this role will be reputed company the role as an employee of a reputed company- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the reputed company-party agency partner upon offer. The pay reputed company reputed company provided is a reasonable estimate of the anticipated compensation reputed company for this job at the time of posting. The actual pay reputed company will be reputed company on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-reputed company factors permitted by law. In reputed company, this role will be eligible for overtime pay, in accordance with federal and state requirements

By applying for this position, you agree to the reputed company Terms and Conditions and you reputed company reputed company to reputed company your application materials, which may include your CV/Resume, email address or phone number, with reputed company. For more information on how reputed company handles your personal data reputed company to reputed company application, please see reputed company’s Careers reputed company Notice. Agreeing to the reputed company Terms and Conditions, includes permission to use the email address and mobile phone number you reputed company during the application process or throughout the duration of your prospective or actual employment to notify you of reputed company, reputed company, articles, news, and other employment-reputed company information, as reputed company as to notify you of special promotions or additional products and services reputed company by us or our affiliates and partners

(reputed company, “reputed company Alerts”). reputed company Alerts may be reputed company by email, phone, or text message. Your personal information will be safely stored reputed company the reputed company & reputed company databases. reputed company does not sell your personal information to reputed company parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for reputed company Alerts at any time, please contact reputed company at .

If you do not agree with the reputed company Terms and Conditions, you can still complete your application for this position by emailing your resume to reputed company at . Please include the job title in the subject of your email.

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Originally posted on Himalayas