Regulatory Affairs Director
Job Description
We are seeking a highly skilled and experienced Regulatory Affairs Director to lead our regulatory strategy and ensure compliance with all relevant regulations. As a key member of our team, you will be responsible for developing and implementing regulatory strategies that align with our business objectives.
Your primary focus will be on ensuring the successful launch and ongoing compliance of our products in the US and European markets. You will work closely with cross-functional teams to identify and mitigate potential risks and develop effective solutions.
Key Responsibilities:
* Develop and implement regulatory strategies that meet company objectives.
* Lead the preparation and submission of regulatory documents, including 510(k) and CE Mark applications.
* Manage relationships with regulatory agencies, including the US FDA and EU authorities.
* Collaborate with Quality Assurance to ensure post-market surveillance and vigilance activities meet applicable standards.
* Provide strategic advice and support on all regulatory matters.
Required Skills and Qualifications
To be successful in this role, you will need to have a strong background in regulatory affairs, with experience in the medical device industry. You should possess excellent leadership and communication skills, as well as the ability to work effectively in a fast-paced environment.
* Bachelor's degree in Engineering, Life Sciences, or a health-related field.
* 10+ years of experience in the medical device industry, with a minimum of 3 years in a leadership or management role.
* In-depth knowledge of US FDA and EU medical device regulations (including MDR).
* Proven ability to handle complex regulatory submissions and interactions.
* Excellent organizational, leadership, and communication skills.
Benefits
This is an exciting opportunity to join our dynamic team and contribute to the success of our company. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
Candidate Requirements:
* A self-starter with a hands-on approach and the ability to thrive in a dynamic, entrepreneurial environment.
* Previous experience in an SME or medtech startup is highly desirable.
Please contact us for further information.