Senior RAQA Manager
Senior RAQA Manager
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Job Description
Primary Function of Position:
Act as a representative of Intuitive Surgical Ltd (UK Responsible Person) importer and distributor under the UK medical device regulations. Management of regulatory operations postmarket surveillance QMS liaison with Corporate & global RAQA teams advocacy with government bodies and manufacturer associations across assigned markets (Especially UK and Ireland). Ensure proper liaison with sales marketing and service teams as well as all other enabling functions.
Roles and Responsibilities:
Regulatory Compliance & Quality System
- Fulfill the role of UK Responsible Person contact and site management representative
- Responsible for ensuring compliance of the quality system activities (Nonconformance management audit/inspection economic operator obligations post market surveillance) in the target markets
- Partner with domestic and international teams to develop and execute quality management system strategies in accordance with corporate policies and local or international regulation
- Stay informed about regional regulatory changes and updates and implement necessary adjustments to the QMS.
Business Support
- Join the leadership team to ensure compliance of all Intuitive Surgical Ltd activities with applicable regulation; guide and influence operational decisions accordingly
- Represent Intuitive Surgical with competent authorities (eg MHRA HPRA) and manufacturer associations (eg ABHI IBEC) to develop and strengthen partnerships and monitor and implement regulatory trends
- Support public procurement activities and customer satisfaction by ensuring timely and accurate RAQA input
Additional activities
- Other projects may be assigned as necessary
- Travel: up to 20
Qualifications :
Required Knowledge Skills and Experience:
- At least 8 years experience in medical device industry operating according to US or EU regulation including at least 3 years in medical devices quality system management quality manufacturing or regulatory affairs
- A Bachelor degree Engineering or Masters degree in medical technology life sciences or similar (or equivalent work experience in similar function)
- Deep knowledge of EU MDR 2017/745/EU UK MDR 2002 and ISO 13485:2016
- Ability to work autonomously and exercise daily judgment based on above regulatory knowledge.
- Demonstrated organizational and planning skills including action oriented and cando attitude focused urgency and driving for results
- Excellent verbal and written communication and presentation skills ability to distill complexity and provide clear and actionable direction
- Orientation for work result details with emphasis on accuracy and completeness
- Computer literacy (PC Microsoft Word/Excel/PowerPoint Outlook)
- Language: Fluent English
Preferred Knowledge Skills and Experience:
- Lead auditor certification for ISO 13485 and knowledge of WW regulations
- RAC certification is a plus
- Team management experience of small team size associated with goals objectives definition / people development.
Additional Information :
Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
