Vice President of Regualtory Affairs

Proclinical is currently recruiting for a Vice President of Regulatory Affairs with a life sciences start-up located in Princeton, NJ. As the Regulatory Affairs Vice President, you will be responsible for leading the preparation of US and international regulatory submissions to support global product launches, product development, and post-approval product life cycle.

Job responsibilities:

• Manage and build a Regulatory and Quality Affairs department, manage timelines, and address gaps in planning and resourcing.
• Develop the company's US and international regulatory strategy and obtain required regulatory clearances for the company's products.
• Provide compliance subject matter expertise across a broad range of technical areas, including software as a medical device.
• Oversee and manage the implementation and maintenance of the company's quality program.,
• Work with multidisciplinary departments to meet established objectives and deadlines.
• Assesses and communicates regulatory issues and trends to senior leaders.
• Analyze, recommend, and implement solutions to regulatory challenges for efficient risk management.

Skills and Requirements:

• 10+ years of regulatory affairs experience.
• Expertise in US and global medical device regulations, requirements, and standards.
• Demonstrated excellence in serving as a regulatory liaison and developing regulatory strategy including a broad understanding of international regulations, processes and issues related to medical devices.
• Flexibility and responsiveness in managing multiple projects.
• Previous experience managing a team.
• Evidence of being a critical strategic thinker who is solution oriented.
• Regulatory affairs certification (RAC) a plus.
• Knowledge of both GCP and GMP regulations.

If you are having difficulty in applying or if you have any questions, please contact Nick Walker at (+1) 646-367-2908 or n.walker@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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