Regulatory Affairs Director - Medical Device Development - new york city - Hobson Prior

Hobson Prior new york city

1 week ago

Description

Senior Director of Regulatory Affairs Job Description

Hobson Prior is a leading life sciences recruiter dedicated to matching talented professionals with exceptional opportunities in the industry.

We are currently seeking a highly motivated and experienced Senior Director of Regulatory Affairs to join our team. This role will play a crucial part in ensuring regulatory compliance and supporting the development and commercialization of innovative medical devices.

About the Role:

This is an exciting opportunity for a seasoned regulatory affairs professional to leverage their expertise in device development within the biotechnology or pharmaceutical industry. The successful candidate will have a strong understanding of global regulatory requirements and experience in preparing and submitting regulatory documents.

Main Responsibilities:

Develop and implement regulatory strategies for medical devices, ensuring seamless compliance with global regulations.
Prepare and submit high-quality regulatory documents to authorities, meeting stringent deadlines and expectations.
Provide expert guidance and support to cross-functional teams throughout product development, ensuring regulatory requirements are met at every stage.
Stay up-to-date on industry trends and regulatory changes, providing proactive insights to drive business growth and minimize risks.
Conduct thorough risk assessments and develop effective strategies to address challenges and ensure compliance.
Review and approve labelling and promotional materials for regulatory compliance, guaranteeing consistency and accuracy.

Requirements:

Degree in a scientific discipline (e.g., biology, chemistry, pharmacology).
At least 5 years of experience in regulatory affairs, with a focus on medical device development.
In-depth knowledge of global regulatory requirements for medical devices, including FDA and CE mark regulations.
Proven track record of preparing and submitting successful regulatory documents.
Excellent analytical, problem-solving, and communication skills, with the ability to work effectively in a fast-paced environment.
Strong attention to detail and organizational skills, with the ability to manage multiple projects simultaneously.

What We Offer:

Hobson Prior offers a competitive salary range of $120,000 - $180,000 per annum, commensurate with experience, as well as a comprehensive benefits package and opportunities for career growth and professional development.

If you are a motivated and results-driven individual with a passion for regulatory affairs, we encourage you to apply for this exciting opportunity. Please click 'Apply' to upload your CV and cover letter, and we will be in touch shortly.

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