| Asensus has a unique opportunity for a Regulatory Affairs Manager to join our team and help bring an innovative digital surgery product to market. The Regulatory Affairs Manager is responsible for developing global regulatory strategies for surgical robotic medical devices. The individual will plan, prepare, and submit FDA premarket 510(k) submissions and international product registrations. This role will oversee and be consulted on post-market surveillance requirements for global regulatory bodies and is expected to have deep product and regulatory knowledge in order to make decisions independently. This role provides regulatory leadership on project teams as well as mentoring the work of other specialists and associates on the Regulatory team. At Asensus, we are digitizing the interface between the surgeon and patient to pioneer a new era of Performance-Guided Surgery by unlocking the Clinical Intelligence to enable consistently superior outcomes and a new standard of surgery. Our employees are especially passionate about the work they do and thrive in a collaborative environment that fosters creative solutions to complex problems. The work is challenging, but everyone comes to Asensus looking for a fulfilling career, and that's exactly what they find. What You’ll Do - Authors, prepares, and submits Premarket 510(k) submissions to US FDA for medical devices
- Serves as the regulatory team member on product development projects with minimal oversight
- Partners with cross functional teams by providing regulatory guidance and support to product development teams for strategic planning for 510(k) submissions, CE marking and international product registrations
- Reviews technical protocols, data, and reports generated by other departments or test facilities and analyzes for alignment with international standards and regulations
- Prepares regulatory assessments and provides regulatory approval for product changes
- Engages FDA regulators, verbally and through written communications to discuss pending or new submissions, regulatory requirements, etc.
- Leads development of on-product labeling; advises and approves advertising and promotional materials in accordance with regulations and device-specific regulatory clearances/approvals
- Prepares establishment registrations, medical device listings, as well as obtains and maintains Certificates to Foreign Governments and Certificates for Export
- Prepares EU technical files/STED files for CE marking and international product registration dossiers
- Interprets regulations and provides regulatory guidance to global teams
- Provides Regulatory Affairs support during internal and external audits
- Keeps current in regard to US and international medical device regulations, guidance documents and international standards
- Develops best practices for Regulatory Affairs processes
- All Other Essential Duties as directed
What You Bring - Bachelor's Degree in engineering, scientific discipline or related field
- Minimum of 7 years of Regulatory Affairs experience in a medical device firm
- Experience preparing 510(k) submissions or PMA submissions for medical devices
- Experience interacting with US FDA is required
- Regulatory Affairs Certification (RAC) preferred
- A solid knowledge of US FDA regulations and Quality System regulations
- Experience preparing FDA Pre-Submissions is preferred
- Experience preparing CE technical files or STED files and international product registrations is preferred
- Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively verbally and in writing
- Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive
- Ability to work independently and as a member of a team in a timeline-driven environment with limited direct oversight
- Being detail-oriented while having the ability to handle multiple projects/tasks
- Working knowledge of software programs including, MS Word and Excel, Project management tools (MS Project, SmartSheet), Adobe Acrobat/Nuance PDF, Google applications, and flow charting tools such as Visio or Lucidchart preferred
What We Offer - A culture driven to achieve our mission and deliver remarkable results
- Coworkers committed to collaboration and winning the right way
- Quality products that improve the lives of our customers and patients
- Ability to discover your strengths, follow your passion and find your own rewarding career
- Flexible, engaging work environment
- A competitive benefits package
|
