Regulatory and Risk Manager



Regulatory and Risk Manager


Birmingham, United Kingdom 

Job Type:


Job Views:






Job Description:

Our client is looking for a permanent Regulatory and Risk Manager to be based at their headquarters near Birmingham.Reporting to the Director of Quality and Regulatory Affairs this is not a stereotypical regulatory and risk based role, as you would expect, our client is looking for someone gregarious, forward thinking, motivated, is a proven risk professional, and great at leading people and ideally possess a proven track record in a similar role with a Global manufacturer in the Healthcare, Medical sector, Pharmaceutical or life science sectors.We are looking for an individual who is keen to work in an environment where they can genuinely develop and implement a range of regulatory and risk mitigating improvements strategies in an agile manner. The successful incumbent will be required to plan, manage and oversee all regulatory and risk based activities for the Company with the overall objective of achieving set commercial goals.As a Regulatory and Risk Manager you will be required to develop a regulatory strategy to support all target markets, and to maintain regulatory compliance as required.Key Responsibilities for the Regulatory and Risk Manager include;• Directing the company to deliver sufficient depth of evidence to demonstrate regulatory compliance. – every regulatory and quality role, researching different markets (US, FDA inspection, EU, France, Italy Canada, India, Hong Kong, and providing evidence and delivering it to CEO, head of department and Directors) and software engineers for data extraction. • Oversee and be accountable for the vigilance processes (PMS feedback, regulatory changes, adverse events, competitor information, literature searches) required in Europe, US and other relevant markets. – regulatory and scientific research clearance and across US and Europe.• Knowledge of the structure of Vigilance Reports and some clinical evaluation reports and post clinical follow ups report in line with the relevant plans.• Defining the appropriate regulatory pathways for entry into global markets and support other members of the company in understanding the regulatory pathways. Work with sales team and put together practical medical devises and training them, regulatory route they should take.• Providing advice on possible approaches to de-risking and accelerating project completion. Intrinsic part of steering group, with sales, marketing and product development and introduced risk management into • Part of matrix team and joint overseeing responsibilities for project managing product development to market and business plans are executed • Overseeing regulatory intelligence and reviewing competitors route to market and reviewing 510(K) on the FDA website. Ensuring subject matter expertise and advice on approaches taken by other companies for comparable products in satisfying regulatory requirements.• Providing risk assurance support into the design and development process, to assure risk consideration and acceptability as ALAP (As low as possible) throughout the product development lifecycle. Software medical devise – implemented ISO 14971, introduced risk framework for software lifecycle.• Facilitating managerial leadership for team members, ensuring that there is a common agreement on strategy, priorities and deadlines, and to maintain a strong understanding of delivery against plans and targets. 2 direct reports at the moment Requirements/Qualifications• Strong understanding of regulatory standards and their implementation in a Medical Device framework i.e. Medical Device Directive (93/42EEC), ISO 13485 – audit and lead auditor, ISO 14971, IEC 60601 electric safety (some) ,IEC 62366, IEC 62304, 21 CFR 820,21CFR 807, 21 CFR 11.In addition to an excellent basic salary, commission scheme and top level benefits package, this global blue chip company will offer you the opportunity to work for one of the world's leading life science and medical device manufacturers where you can take personal responsibility for your career growth and development.• Experience in working with PEMS (Programmable Electrical Medical Systems) or equivalent high-integrity software-intensive systems i.e. complex devices requiring multidisciplinary development effort (mechanical engineering, software, electronics, system integration, pneumatics, fluid mechanics, etc.).• Experience of working with risk management, regulatory requirements, document management systems, issue management systems.• Trained in application of IS014971 an advantagemarketing experience in either medical devise design, medical manufacturing, life sciences or Pharmaceutical sectors • Ability to work with external bodies.• Good team player and effective communicator.• Flexible approach to hours.• Ability to operate at strategic and operational levels.• Ability to identify strategic and operational issues and develop plans to address.• Ability to lead; demonstrating assertiveness, team building and management skills.• Effective communicator.• Articulate, persuasive personality.• Extensive experience working in product development & delivery.• Sound technical knowledge of product base and application
Company Info
Swindon, Wiltshire, United Kingdom

Company Profile