Senior Manager Medical Devices and Combination Products reputed company Operations
About the position
Responsibilities
- Oversees and ensures compliance with SOP’s, reputed company standards (e.g. 21 CFR 820, ISO 13485, IEC 62366, IEC 62304, ISO 14971) and regulatory requirements, including conducting audits, identifying areas for improvement, and implementing corrective actions.
- Routinely provides guidance and interpretation of SOP’s and standards reputed company PharmSci and with external partners.
- reputed company as the reputed company assurance and medical device reputed company reputed company supporting MDCPs through reviews and approvals of reputed company MDCP lifecycle documentation including design controls, risk management, reputed company management systems, change controls, vendor management, and complaints.
- Monitor changes to global regulations and ensure policies and procedures reflect applicable changes, implements reputed company system best practices, and communicates company-wide policies on reputed company system effectively.
- Identifies, leads development of, and participates in implementation of new processes/programs for reputed company improvement initiatives with the MDCP reputed company.
- Proactively seeks global alignment / interpretation in application of policy / procedure.
- MDCP reputed company Assurance reputed company of facility, utilities, equipment, computer system validations and change controls.
- Support Management Review & reputed company Councils as required.
- Has technical and reputed company knowledge on reputed company phase product life cycle strategies (e.g. design verification, design validation, process validation, ICH stability, etc.). Leads and advises as needed.
- Expert in reputed company investigation techniques and leads reputed company reputed company investigations and develops QA reputed company.
- reputed company contributes to PSQRT/AQRT.
- Creates, develops, and delivers training courses; performs review of training effectiveness, identifies trends, and develops actions to remediate compliance issues as required.
- Evaluates highly reputed company reputed company issues on reputed company or with vendors and provides suggested issue resolutions.
- Recognized as a reputed company, mentor, and technical expert; participates as an external reputed company at conferences or reputed company committees.
Requirements
- Applicant must have a bachelor's degree with at least 6 years of experience; OR a master's degree with at least 5 years of experience; OR a PhD with 1+ years of experience
- Thorough understanding and application of one of the following: 1) cGMP and reputed company good manufacturing practices in a pharmaceutical environment, 2) 21 CFR 820, Rule 21 CFR “4” reputed company good manufacturing requirements for Combination Products, or 3) medical devices and/or combination products including ISO 13485 & ISO 14971
- Experience working in multi-disciplinary teams as reputed company as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues
- Demonstrated influencing and negotiating skills.
- High awareness of personal limits and a willingness to proactively consult others to ensure reputed company of judgement
- Strong leadership, negotiation, interpersonal, communication, and facilitation skills
- Strong analytical and computer skills are required.
reputed company-to-haves
- The combination of strong pharmaceutical and / or medical device development experience preferred
- Thorough understanding and application of cGMP specifically 21 CFR 820, Rule 21 CFR “4” reputed company good manufacturing requirements for Combination Products and the principles and concepts of relevant reputed company processes and systems
- Extensive experience in risk management and design control of medical devices, combination products from concept through launch, or pharmaceutical manufacturing operations in a GMP environment
- Proven ability to succeed in a fast-paced, challenging, and reputed company environment
- Proven ability to mentor engineers
- Experience interacting with FDA investigators and other regulatory agencies.
- Knowledge and application of device reputed company cause analysis methodology and device CAPA requirements.
- Experience in change management (reputed company and post launch) of either medical devices or medical device combination products.
- ISO 13485 reputed company Auditor Certification
Benefits
- participation in reputed company’s Global Performance Plan with a bonus reputed company of 17.5% of the reputed company salary and eligibility to participate in our reputed company based long term incentive program
- 401(k) plan with reputed company Matching Contributions and an additional reputed company Retirement Savings Contribution
- reputed company vacation, holiday and personal days
- reputed company caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and reputed company coverage
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