Regulatory Affairs and Quality Manager
What you’ll do
You will be responsible for handling pre-market submissions to the FDA and managing CE Medical certification interacting with notified bodies in the EU. You will also be responsible for the quality within Empatica defining SOPs related to product design, development, production and support. You will conduct internal audits and training and will supervise external audits from external entities.
You will join an elite team of hard-working and passionate people and will be involved in:
- Serving as the Regulatory representative on cross-functional teams supporting products throughout the stages of development and commercialization.
- Defining regulatory strategies and plan for marketing medical devices
- Participating in product meetings
- Creation and maintenance of SOPs
- Creation and maintenance of Design history files
- Creation of 510K (or DeNovo) documentation
- Conducting management reviews
- Management of non Conformities
- Auditing to suppliers
- Collection of Clinical trial results
- Collection and supervision of quality index
- Implementation of corrective actions
- Coordination of regulatory consultants
- Contacting FDA and other Regulatory authorities for review status updates for pending applications and supplements
- Evaluating proposed changes to approved products for potential Regulatory impact and gather required data as needed to defend a Regulatory filing strategy
- Providing regulatory risk assessments and intelligence on Empatica devices
- Reviewing technical reports, summary documents and change controls for appropriate content and justifications as well as for adherence to regulatory guidelines, strategies, and commitments.
- Communicating regulatory requirements and expectations across the company.
- Training employees on regulatory aspects
Why work at Empatica
At Empatica you will be able express your potential. We need people that can take decisions and achieve results with total independence. In addition we need creative people that are able to find solutions that could be more efficient in terms of time or resources.
As the ideal candidate for this position you:
- Have a genuine interest, passion and motivation for Empatica’s mission.
- Have a strong academic background (Masters degree is a minimum), preferred in the engineering field.
- Past experience as a quality or regulatory manager in a medical device manufacturing company
- Strong knowledge in the following international standards and directives
- U.S. regulations, 21 CFR Part 820 for a Class II medical device
- Directive 93/42/CEE annex II
- UNI CEI EN ISO 13485:2012
- ISO/IEC 27001:2013 – information security
- U.S. regulations, 21 CFR Part 11
- UNI CEI EN ISO 14971 :2012 – risk management
- CEI EN 62304:2006
- Bench testing standards
- EMC: 60601-1-2:2014 (Fourth Edition), FCC and Industry Canada
- Safety: IEC 60601-1:2005, IEC 60601-1-11:2010
- Biocompatibility: ISO10993-5:2009, ISO10993-10:2010 and ISO10993-10:2010
- Usability: IEC 60601-1-6:2010 and IEC 62366:2007
- Past experience in creating SOPS and design history files and documentation for FDA and EU notified body.
- Preferred English native speaker
The ideal candidate for Empatica:
- Is a reliable and effective worker; working in a fast growing startup is not for everyone.
- Is creative, fun and easy to work with.
- Is self-motivated, with good leadership skills.
- Is a critical thinker and always questions dogma, status quo, and the conventional way of doing things.
- Is able to manage a variety of assignments.
- Is detail oriented and highly organized.
We expect a lot from you, but your efforts will be rewarded by great benefits:
- Competitive salary
- The position is flexible between the Milan HQ or Boston HQ. Plus we have an amazing beach summer office in Sardinia, Italy!
- MacBook Pro
- Flexible work hours
- Free cookies, if you deserve them
- Much more…