Regulatory Affairs Leader
7 days ago
At Lifelancer, we connect talent with opportunities in life sciences, pharma, and IT. Our platform helps professionals grow their careers in a variety of domains.
We are seeking an experienced Regulatory Affairs professional to join our team as a Senior Manager. This role will play a crucial part in supporting regulatory needs across the business, from product development to post-market requirements.
The ideal candidate has over 10 years of experience in Regulatory Affairs, with a strong focus on IVD and POC products. They have hands-on experience with US regulatory submissions, including 510(k) and PMA, and can lead these processes effectively. The selected individual will act as the regulatory liaison between teams, leadership, and regulatory agencies, ensuring seamless communication and collaboration.
This is a US-based remote-eligible position, with anticipated travel up to 30%. If you're a seasoned professional looking for a new challenge, this could be the opportunity for you.
About the role:
- Lead regulatory submissions processes, utilizing expertise to anticipate and address challenges
- Serve as the primary point of contact for regulatory affairs within the organization
- Collaborate with cross-functional teams to ensure effective regulatory compliance
About us:
Lifelancer is a talent-hiring platform dedicated to connecting professionals with job opportunities in various industries. We strive to provide a supportive environment where individuals can grow and thrive in their careers.
Key Requirements:
- 10+ years of experience in Regulatory Affairs, specifically with IVD and POC products
- Proven track record of leading successful regulatory submissions, including 510(k) and PMA
- Excellent communication and collaboration skills
What We Offer:
- A competitive compensation package, estimated at $150,000-$170,000 annually
- A comprehensive benefits program
- Opportunities for career growth and professional development
EEO Statement:
Lifelancer is an equal opportunity employer committed to diversity and inclusion. We welcome applications from qualified candidates and aim to create a workplace that values and respects all employees.
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