Regulatory Affairs Lead at Formlabs
To reinvent an industry, you have to build the best team. Join Formlabs if you want to bring groundbreaking professional 3D printers and materials to the desktop of medical and dental professionals all over the world.
We are looking for someone to lead and grow the Regulatory Team and ensure Formlabs products comply with regulatory standards as we bring new products into markets across the globe. Are you excited to take a leadership role in a fast growing company and put your regulatory, quality, and management skills to work? If so, we want you to join as our Regulatory Affairs Lead.
- Lead Formlabs compliance strategies and regulatory activities; ensure business needs and regulatory initiatives are in alignment, and the company meets overall operational objectives.
- Liaise with regulatory bodies and third-party service providers to understand requirements for successful product submissions, clearances, and approvals for Formlabs products.
- Responsible for regulatory submissions of Formlabs new or modified medical materials to FDA and other global regulatory bodies.
- Define and drive regulatory strategies for new product development; provide guidance for R&D, Sales, Marketing, and Manufacturing with the goal of commercializing Formlabs new medical & dental products.
- Lead and manage complex issues with multiple competing priorities that have a direct impact on operations and opportunities. Partner with other functional areas (including Manufacturing, Quality, Product, R&D, Marketing, Customer Service, Legal and Compliance) to deliver solutions and execute tactics that further business objectives in an effective and compliant manner.
- Continuously improve and monitor the quality management system to demonstrate compliance. Identifying gaps in current operating model to improve overall efficiency and sophistication as the company matures.
- Manage, coach and develop the Regulatory Team to ensure skills are aligned with a high performing organization.
- Interact with outside consulting groups and vendors to manage activities necessary for completing key initiatives.
- Have 7 or more years of relevant experience in regulatory functions.
- BA/BS in Life Sciences or a Healthcare related field is required.
- Have extensive experience in regulatory compliance relevant to medical devices. A demonstrated track record of success in regulatory filings for US (510(k)) and other key countries/regions such as European Community (EC) MDR.
- Hold a broad knowledge of medical device operations and quality guidelines; working knowledge of ISO-13485 or other quality systems.
- Are capable of strategic thinking and proposing innovative solutions to regulatory problems. You are results oriented, with a strong sense of urgency and willingness to set and drive aggressive project timelines.
- Have outstanding written and oral communication and negotiation skills. Ability to present and effectively communicate complex concepts to audiences of various backgrounds and knowledge levels.
- Maintain a high level of personal and professional integrity with a strong work ethic and the ability to work independently with minimal direction.
- Are know for your top-notch interpersonal, analytical, organizational, and leadership skills, and ability to stay up to date on current regulations.
- Experience in 3D printing medical device regulations.