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Proclinical Staffing
Boston, MA, United States
Regulatory Affairs Director - Permanent - Boston, MA Proclinical is seeking a Regulatory Affairs Director who will be responsible for the development and execution of regulatory strategies for assigned programs. This is a permanent position based in Boston, MA. Primary Responsibilities: The successful candidate will work collaboratively with variou
Job Source: Proclinical StaffingApellis Pharmaceuticals
Waltham, MA, United States
Position Summary: The Director, Regulatory Affairs will be responsible for ensuring the development and delivery of science-based, solution-oriented, and globally aligned regulatory strategies for accountable program(s). Key Responsibilities Include: Ensure alignment of global regulatory strategies with Apellis corporate objectives. Collaborate
Job Source: Apellis PharmaceuticalsDyne Tx
Waltham, MA, United States
Our commitment to people with muscle diseases Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases.With its proprietary FORCE platform, Dyne is developing modern oligonucleotide therapeutics that are designed toovercome limitati
Job Source: Dyne TxPAREXEL
Billerica, MA, United States
Great opportunity to use your regulatory expertise and lead a truly exceptional team! As a Director, Regulatory Affairs , you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product app
Job Source: PAREXELThe Steely Group
Cambridge, MA, United States
The Director, Regulatory Affairs will serve as a Health Authority liaison and Regulatory Project Leader for our clients multiple projects in various stages of development. This individual will establish and communicate regulatory strategies and mana Regulatory Affairs, Director, Regulatory, Leader, Product Development, Project Lead, Business Servic
Job Source: The Steely GroupPAREXEL
Billerica, MA, United States
Great opportunity to use your regulatory expertise and lead a truly exceptional team! As a Director, Regulatory Affairs , you will use your expertise to lead and mentor a team of high-performing Regulatory Affairs professionals; provide invaluable strategic, technical, and regulatory advice to help clients with their various innovative product app
Job Source: PAREXELBiofourmis
Needham Heights, MA, United States
The Director of Quality and Regulatory Affairs is responsible for developing and implementing the long range regulatory and compliance strategy by leading and directing the organizational development, processes and activities required to support the Biofourmis remote patient monitoring platforms and pharma partnerships on a global basis. Reporting
Job Source: BiofourmisRapport Therapeutics
Boston, MA, United States
As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition
Job Source: Rapport TherapeuticsNeedham, MA, United States
The Director of Quality and Regulatory Affairs is responsible for developing and implementing the long range regulatory and compliance strategy by leading and directing the organizational development, processes and activities required to support the Biofourmis remote patient monitoring platforms and pharma partnerships on a global basis. Reporting to the Sr. VP of Q&R, the Director will have responsibility for the following aspects of customer based solutions;
Establishing and maintaining the product compliance strategy per market requirements
Supporting customer sales and business development activities (including sales proposals, contracts, and audits) requiring regulatory guidance and oversight.
Leading product submissions, Competent Authority interactions (Q-Subs), and associated regulatory operations and processes.
Managing compliance to the requirements established by applicable Regulatory Agencies (Competent Authorities)
Ensuring consistency and delivery of product and services within the implemented market requirements
Managing, reviewing, and approving finished product and service specifications prior to market launch and implementation
Establishing and overseeing key processes that require timely and effective execution
Supporting and guiding product development, service, and manufacturing teams to ensure compliance to applicable requirements and regulations.
Job Overview:
Ensures all products are released to established procedures and meet required policies, regulations, and customer requirements.
Provides guidance and support on administrative and operational activities to ensure the effective achievement of business objectives with full quality and regulatory compliance
Has broad expertise and unique domain knowledge in the areas of pharmaceutical, software, and hardware development, clinical trials systems and processes, manufacturing / distribution, regulatory submissions, and quality management.
Has the necessary technical, educational, and work experience to become highly knowledgeable with the organizations products and services.
Regularly interacts with company executives, leaders and customers to collaborate and formulate plans to achieve desired outcomes.
Works on complex challenges that require in depth knowledge of quality and regulatory principles and practices.
Oversees and ensures proper staff allocation, support and development within departmental budgets.
Manages direct staff and personal involvement with broad cross functional teams to deliver high quality propositions and solutions in a compliant and efficient manner.
Minimum Requirements
Typically requires a scientific degree within engineering, data science, computer science, or other relevant technical discipline with 8 years similar experience in regulated industry, 5 years with a Masters, and 3 years with a PhD.
Experience with Pharma / Biotech product development, Clinical trial management, and associated documentation.
Working knowledge of appropriate global medical device regulations, requirements, and standards such as 21 CFR parts 50 and ICH R2 (GCPs), 803, 806, 812, and 820, ISO 13485, ISO 14971, IEC 62366, EU MDR, Canadian MDR, and ANVISA.
10+ years in a regulated environment such as medical device, pharmaceutical, or other relevant fields.
5+ years of management experience
Experience with Software as a Medical Device, IEC 62304 / 82304, Digital Therapeutics, and software development practices a plus
Base salary range for this position is $165,000 to $200,000 based upon experience.
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Email Alert for Director, Regulatory Affairs jobs in Needham, MA, United States
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