Senior Regulatory Affairs Manager
Senior Regulatory Affairs Manager
Posted on :
17-03-2025
Employer Active
1 Vacancy
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Job Description
Overview
Position Summary:
Responsible to manage a regulatory team to oversee all aspects of the premarket or postmarket regulatory activities required to maintain compliance to US FDA Health Canada European IVD Directive 98/79/EC and European IVD Regulation (EU) 217/746 MDSAP country regulations as well as other country regulatory agencies. Provides regulatory leadership to the Company reporting to executive management on the status of pre and postmarket projects.
- Postmarket RA Manager: Provides regulatory oversight on all aspects of postmarket requirements including but not limited to the management of field corrections and removals worldwide vigilance reporting device modification assessments for registration requirements and management of the postmarket surveillance program to ensure compliance with applicable domestic and international regulations.
Responsibilities
Key Accountabilities
Essential Functions:
Postmarket RA Responsibilities (as assigned):
- Acts as the regulatory lead on the risk analysis worksheet (RAW) reviews for onmarket product to identify potentially reportable incidents and field corrections/removals.
- Leads the regulatory team that supports QA/RA Milan offices and Werfen affiliate offices for adverse event filings and responses to EU Competent Authorities in compliance with MEDDEV 2.121.
- Oversees the timely filing of adverse events in the United States and Canada and ensures that the affiliate countries file adverse events per local regulations and time lines (e.g. Australia Brazil Japan and S. Korea).
- Manages all aspects of field corrections and removal for onmarket product authoring field communications orchestrating the timely notification of customers and regulatory agencies (as required) preparing regulatory strategy overseeing the team that assembles necessary support documentation and product information. Interfaces directly with US FDA and Health Canada and supports local affiliates and dealers in meeting their country regulations and time lines.
- Leads the regulatory team in the assessment of device modifications to ILlabeled medical devices filing with US FDA and Health Canada directly (as needed) ensuring that necessary country regulatory filings are made prior to implementation in compliance with their local regulations (e.g. Australia Brazil Japan and S. Korea).
- Leads the postmarket surveillance program in compliance with worldwide regulatory requirements.
- Leads team that maintains FDA establishment registrations and device licenses UDI database Canadian license renewals and updates Health Canada in the event of a change in the ISO certificate per US and FDA regulations.
- Leads team that works with local affiliates in Australia Brazil and Japan to ensure MDSAP country regulatory requirements are met and the documentation is available.
- Reviews and signs Change Orders for onmarket product.
- Develops and maintain regulatory related postmarket procedures/policies.
- Other areas as needed to meet worldwide regulations.
Budget Managed (if applicable):
- N/A
Internal Networking/Key Relationships:
- All Werfen departments in multiple locations. Affiliate and Sister Division interface.
Skills & Capabilities:
- Effective verbal and written communication in individual and group settings with proven experience authoring regulatory submissions or field communications
- Very detail oriented with solid organizational skills and the ability to meet deadlines
- Able to manage competing projects with strong planning/prioritization skills
- Strong leadership skills both at the direct report level and for interfacing with crossfunctional departments executive management and external regulatory agencies
Qualifications
Minimum Knowledge & Experience Required for the Position:
Postmarket RA Manager:
- Requires a Bachelor degree preferably in regulatory or science related areas
- Minimum of 7 years of management experience in the medical device or IVD industry
- Experience with US FDA and Health Canada adverse event and field correction/removal regulations and guidelines required with experience in international adverse event reporting and field correction/removal actions a major plus
- Experience in managing a postmarket program preferred
- Knowledge of FDA 21 CFRHealth Canada Medical Device Regulation European IVD Directive 98/79/EC and European IVD Regulation (EU) 217/746 MDSAP Companion Document and ISO 13485 preferred
International Mobility:
- Not required
Travel Requirements:
- Some travel required up to 20
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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