Are you a regulatory affairs professional with a passion for ensuring compliance and driving strategic initiatives in the medical device industry? A reputable Medical Device Company, located in the sunny city of San Diego, California, is seeking an experienced Director of Regulatory Affairs to lead their regulatory efforts and ensure adherence to global standards.
About the Company:
This company is a leader in medical device innovation, dedicated to developing cutting-edge solutions that enhance patient care and improve outcomes. With a strong emphasis on quality, compliance, and continuous improvement, they are shaping the future of healthcare technology. As they continue to expand their product offerings and navigate the regulatory landscape, they are seeking a dynamic regulatory leader to join them in driving regulatory excellence.
Responsibilities of Director of Regulatory Affairs at Medical Device Company:
As the Director of Regulatory Affairs at the Medical Device Company, the selected candidate will be responsible for:
- Regulatory Strategy: Developing and implementing comprehensive regulatory strategies to ensure product approvals and compliance with global regulations.
- Regulatory Submissions: Leading the preparation and submission of regulatory documents to health authorities, including FDA, EMA, and other international agencies.
- Compliance Oversight: Ensuring ongoing compliance with all applicable regulations, standards, and guidelines throughout the product lifecycle.
- Regulatory Intelligence: Monitoring changes in regulatory requirements and maintaining up-to-date knowledge of the regulatory environment to proactively address potential impacts on the company.
- Cross-functional Collaboration: Working closely with R&D, quality, and manufacturing teams to provide regulatory guidance and support product development and commercialization.
Qualifications:
To excel in the role of Director of Regulatory Affairs at the Medical Device Company, candidates should possess:
- Extensive experience in regulatory affairs within the medical device or pharmaceutical industry, with a proven track record of successful regulatory submissions.
- In-depth knowledge of FDA, EMA, and other global regulatory requirements and processes.
- Strong leadership and management skills, with the ability to collaborate effectively with cross-functional teams.
- Excellent communication and interpersonal skills, with the ability to effectively engage and influence internal and external stakeholders.
- A strategic mindset and the ability to develop and execute regulatory strategies that support business objectives and drive compliance.
How to Apply:
Qualified candidates interested in the Director of Regulatory Affairs role at the Medical Device Company are encouraged to submit their resume and a compelling cover letter outlining their qualifications and vision for the role. Join this team in ensuring regulatory excellence and shaping the future of medical device innovation!
