Based in Formello (Rome, Italy) , the Regulatory Affairs and Quality Assurance (RAQA) Manager has a dual responsibility:
- Dedicated to a product division, to support all RAQA activities to support Sales& Marketing in Europe;
- For managing the local Italian RAQA team/function of the local distribution entity.
The job holder’s through his/her leadership, is ensuring that the organization is meeting RAQA European and local requirements
The job holder’s responsibility is to ensure that activities placed under his leadership are run and built for sustainable long term commercial growth around core ethics, regulatory and quality working practices.
He/ she will be responsible to lead the RAQA team to bring it, to the next level in term of performance and support of Sales & Marketing.
- He/She is part of the local Leadership team and part of the European RAQA Leadership team;
- He/She is the European divisional lead for a division;
- He/she will support the European Sales/Marketing division and product division for all European activities;
- He/She will have to define the budget to support RAQA activities and will be leading the team supporting them and keeping them engaged;
- Ensure his/her team is properly trained to achieve defined goal and objectives;
- Ensure his/her team is fully engaged using the tool available for people engagement and any other initiatives.
- Developing a European submission plan for the 2 next years to support the identified product division;
- Reviewing documentation package for the identified product division prior to European submission;
- Defining a local product submission plan for local activities;
- Ensuring that products are registered in country according defined submission plan to support business growth;
- Ensuring that only registered products are promoted and sold in the country;
- Collaborating with EU registration team assuring coordination of activities.
- Ensuring vigilance system is implemented according to Corporate, European and local requirements to cover product complaints, Product Field actions and Product Holds;
- Coordinating actions with product divisions;
- Communicating in a proactive way to European and local Sales & Marketing and other department involved, Product Field Action to minimize business impact;
- Ensuring that reporting obligations to local competent authority are met.
- Developing all tool part of the QMS at local level according to ISO 9001 standard with a continual improvement approach;
- Keeping local management team informed about Quality management system performance, including any opportunity for improvement;
- Is the QA Management representative in charge of leading Management Review;
- Achieve Performance Metrics: Demonstrate customer focus by achieving corporate, EU and local key quality objectives.
- assuring that required environmental declarations is done on time according to local requirements.
Good distribution practices:
- ensuring that Good distribution practices of Medical Devices are met;
- making sure that national and European regulations and internal Stryker procedures are communicated and understood by Stryker employees and are implemented throughout the organization;
- ensuring that all distributors and Agents fulfill Good distribution practices, EU, local and internal requirements.
- status reporting of activities in regular basis to the RAQA EU RAQA Director, country manager and the European Sales and Marketing VP.
Escalate Issues Effectively:
- determine appropriate escalation of critical regulatory, business or customer issues, and communicate proposed action effectively;
- establish effective collaboration and communication path with the local team, sales& marketing team, EU RAQA teams and product division.
- ensure good relationships with local CA, Managing and facilitating an open dialogue with local Competent Authorities, fulfilling all defined requirement.
- representing Stryker in Assobiomedica, actively participating to Regulatory group.
Collaborate with product division:
- develop strategic and tactical approach with product division contacts (marketing, R&Q, RAQA) to develop needed process and get needed support on key project to support sales growth.
- Pharmacy, Biology, Engineering degree or similar;
- Fluency in English and Italian language;
- Several years of RAQA experience in medical device industry highly desirable;
- people management experience within complex matrix organisation international company environment mandatory;
- leadership skills and experience gained in previous similar roles essential.