We are searching for a Regulatory Affairs Manager for an emerging medical devices company. The The Regulatory Affairs Manager will provide regulatory guidance and oversight to ensure compliance with internal SOPs, local, regional, national, and international regulatory laws, standards, and regulations. The Regulatory Affairs Manager has a broad spectrum of responsibilities spanning regulatory submissions, health authority interactions, compliance and internal advisory activities. staff, managing assets and IT systems.
This well funded private company is positioned to go public next year.
Requirements for the Regulatory Affairs Manager:
- Bachelor’s degree, preferably in a technical discipline, like biology, medical sciences, materials science.
- 4+ years work experience in medical device regulatory affairs, with successful FDA and EU-notified bodies submission experiences.
- Working understanding of US, EU, Canada regulations on medical devices
- Experience with electrophysiology products and platforms
- Experience with medical device product registration and licensing
- Excellent technology skills, particularly expertise with Microsoft Office (Word, Excel, etc.) applications.
- Strong communications skills, oral, written and electronic
- Strong attention to detail and the ability to handle multiple competing projects effectively and work independently with international oversight
- Good record keeping skills
The Regulatory Affairs Manager will:
- Prepare domestic 510k and international submissions, including CE-mark dossiers, for new products and product changes.
- Author dossier content for new device registrations and variations
- Communicates directly with US and international affiliates and regulatory personnel.
- Represent regulatory on product development teams, developing and executing regulatory plans, and providing regulatory impact information for project options.
- Provide support to new and currently marketed products including labeling advice and post market follow up activity requirements.
- Update of Technical Files and Design Dossiers as required along with developing strategy and creation of change notifications to regulatory agencies.
- Assess and respond to deficiencies issued by health authorities in response to new registrations, variations, renewals, etc.
- Provide regulatory assessments for manufacturing change controls
- Document regulatory activities and approvals to support global market authorizations.
- Ensure files maintain compliance with regulatory requirements.
- Acts as a liaison with other departments, e.g., Quality, R&D, supply chain, marketing, and medical affairs for support of major initiatives.
- Support internal and external audits/inspections as required (EU notified bodies, FDA, etc).
- Responsible for ensuring company compliance with Federal, State, and local regulations, policies, procedures and international regulations (e.g. EU-MDR, MDSAP, etc)
- Author and train on regulatory related standard operating procedures and work instructions as required.
Occupational Category: 11-9199.01 Regulatory Affairs Managers