Quality Assurance & Regulatory Affairs Manager - Berkshire

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I am partnering an international Medical Device organisation based in Berkshire to find a confident, commercially minded, Quality & Regulatory Manager to head up the QARA Division.

It is essential that the QARA Manager has both a Quality and Regulatory background but it is preferable that the successful applicant is stronger on Regulatory and held Regulatory centred positions for at least 3 years.

This is a role with international scope and indirect reporting lines into Europe, APAC and USA. The company is looking to grow by at least 20% globally in the next 12 months, making this a fantastic opportunity for someone to shape the QARA strategy and essentially play an important role in growing this business.

Culturally, it is vital that you are excited about a hands-on role in a small team and be self-motivated enough to work autonomously. It is not a requirement that you have experience in international markets or have worked with or taken products through FDA approvals but you must be capable and interested in learning. The QARA Manager will be the company's representative for the likes of the FDA, MHRA and other international bodies so you must be confident and able to do this.

Responsibilities include:

* Regulatory framework analysis and strategy (New and Existing Markets, New and Existing Products)

* Identification, gap analysis & strategy for compliance with relevant international standards

* Regulatory positioning, strategy review for product claims.

* Regulatory positioning, strategy review for clinical substantiation of product claims.

* Management of relationships with notified bodies and regulatory agencies e.g. BSI, FDA, Health Canada, TGA, MHRA etc.

* Product registrations for new and existing markets including North America, APAC & Europe

* Preparation, maintenance and management of technical files to support CE marking of medical devices and non-medical electronic products.

* Management of significant changes with notified bodies and regulatory agencies.

* Transition strategy, planning and implementation for New MDR

* Writing of new QMS Processes for regulatory compliance, and prepare, execute and write up of Audits. Management of CAPAs.

* Management of complaints and vigilance reporting

* Managing the company's audit process and scheduling, including hosting audits and carrying out internal and supplier audits on occasion

Qualifications & Experience:

* Bachelor's Degree in Life Science or Engineering related field

* 5-10 yrs Experience of regulatory affairs in medical devices industry, electro-medical preferred.

* In-depth knowledge of Medical Device regulations (European essential) but Canadian, USA, Australian markets would be an advantage

* An understanding of the role of Regulatory affairs in a business context and the ability to exercise good judgement in determining reasonableness of actions.

* Demonstrable experience of regulatory submissions to major markets.

* Knowledge of global regulatory requirements for Class IIa/b devices.

* Leadership capabilities for working across varied cultures, expertise and backgrounds

* Ability to strategically interpret and respond to request from regulatory agencies.

* Outstanding interpersonal and communication skills for bridging understanding between scientific and business partners, for negotiating timelines, effective international collaboration and ensuring compliance of the organisation with regulatory requirements.

If this sounds like an opportunity that fits your backgroud and experience, apply now! The interview process can move extremely quickly!