Senior Regulatory Affairs Specialist
1 month ago
**Senior Regulatory Affairs Specialist**:
**Locations: Cheshire, United Kingdom; Elst, Netherlands**:
**Resuscitation**:
At ZOLL, we're passionate about improving patient outcomes and helping save lives.
We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Resuscitation division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
Develop, implement, and lead the regulatory regional strategy, in alignment with company goals, for new and sustaining ZOLL Resuscitation products and features.
**Essential Functions**:
- Develop and successfully implement regional regulatory strategies for new and sustaining products/features that result in device approval.
- Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
- Provide strategic regional regulatory perspective during the development, review, and approval of internal and external documentation to support the development and commercialization of assigned product(s).
- Work with RA regional and product teams to ensure that regulatory requirements are appropriately considered and accounted for in programs and projects.
- Work with management on risk assessment and regulatory compliance.
- Support Cross-Functional NPI Project Teams and provide regulatory guidance.
- Maintain current knowledge of regulations and guidance and collaborate with product teams on approvals and disseminate information and generate potential strategies with teams.
- Lead, support, and coordinate with internal and external resources to meet audit and compliance requirements.
- Support a culture of continuous improvement by promoting best practices, fostering innovation, and recognizing and celebrating achievements as well report on key performance indicators (KPIs) to track the progress and impact of continuous improvement efforts.
**Skills Requirements**:
- Experience building regulatory strategies to support successful regulatory affairs team.
- Proven written and verbal communication skills to interface with a variety of stakeholders.
- Ability to create action plans and project deliverables.
- Supports team members in the preparation of suitable written responses to Regulatory Inquiries.
- Experience in the electro cardiology or defibrillation/respiratory space preferred.
- Requires travel (~5% - 10%).
**Required/Preferred Education and Experience**:
- Bachelor’s degree in a relevant science is required. Advanced degree preferred.
- 4+ years of regulatory affairs experience preferably in the medical device industry, with proven experience in electro-mechanical products.
- Regulatory Affairs Certification preferred.
ZOLL is a fast-growing company that operates in more than 140 countries around the world. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation and an entrepreneurial spirit. Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.
-
Senior Regulatory Affairs Specialist
1 month ago
Cheshire, United Kingdom Revorec Recruitment Solutions Ltd Full time**Senior Regulatory Affairs Specialist** **£45,000 to £55,000 per annum + Flexible Working Hours + Progression** **Holidays + Enhanced Pension Scheme** **Office Based, Monday to Friday, 9am - 5pm** **Cheshire** Are you looking for a competitively paid position at an industry leading medical device manufacturing company? Are you looking to work for a...
-
Regulatory Affairs Specialist
1 month ago
Cheshire, United Kingdom Revorec Recruitment Solutions Ltd Full time**Regulatory Affairs Specialist** **£35,000 to £45,000 per annum + Training + Flexible Working Hours + Progression** **Holidays + Enhanced Pension Scheme** **Office Based, Monday to Friday, 9am - 5pm** **Cheshire** Are you looking for a competitively paid position at an industry leading medical device manufacturing company? Are you looking for a role...
-
Senior Regulatory Affairs Specialist
1 month ago
Cheshire, United Kingdom Cast UK Limited Full time**Senior Regulatory Affairs Specialist Cheshire £ Competitive Salary** **Role Profile** Our client is a highly successful medical device business based in Cheshire. They are currently looking to appoint a Senior Regulatory Affairs Specialist to provide regulatory expertise in the research, development and marketing of products. The key purpose of the...
-
Regulatory Affairs Specialist
1 month ago
Cheshire, United Kingdom Cast UK Limited Full time**Regulatory Affairs Specialist Cheshire £ Competitive Salary** **Role Profile** Our client is a highly successful medical device business based in Cheshire. They are currently looking to appoint a Regulatory Affairs Specialist to provide regulatory expertise in the business research, development and marketing of products. The key purpose of the role...
-
Regulatory Affairs Support Administrator
1 month ago
Cheshire, United Kingdom Cast UK Limited Full time**Regulatory Affairs Support Administrator Cheshire £ Competitive Salary** **Role Profile** Our client is a highly successful medical device business based in Cheshire. They are currently looking to appoint a RA Support Administrator to provide administration support to a variety of ongoing regulatory activities. **Key responsibilities will include**: -...
-
Regulatory Affairs Associate
3 days ago
Knutsford, Cheshire, United Kingdom Science Solutions Recruitment Full timeRegulatory Affairs Associate - Cosmetics - Cheshire Would you like to work as a Regualtory Affiars Associate for a global leader in cosmetics? This is a great opportunity to work for a market leader in cosmetics and personal care. As a Regulatory Affairs Associate, you will have further career progression opportunities as the business is recording year on...
-
Regulatory Affairs Associate
3 days ago
Knutsford, Cheshire, United Kingdom Science Solutions Recruitment Full timeRegulatory Affairs Associate - Cosmetics - Cheshire Would you like to work as a Regualtory Affiars Associate for a global leader in cosmetics? This is a great opportunity to work for a market leader in cosmetics and personal care. As a Regulatory Affairs Associate, you will have further career progression opportunities as the business is recording year on...
-
Senior Regulatory Technologist
1 month ago
Cheshire, United Kingdom Science Solutions Recruitment Ltd Full timeSenior Regulatory Technologist - North West This Cosmetics Manufacturer are rapidly growing, they offer a full tailored service to their clients. The manufacture cosmetic products from concept, formulation to packaging and launching! Due to their rapid growth they are looking for a Senior RegulatoryTechnologist. The role of a Senior Regulatory Technologist...
-
Senior Regulatory Services Officer
7 days ago
Cheshire, United Kingdom Spencer Clarke Group Full time**~ Senior Regulatory Services Officer ~** **Spencer Clarke Group** are working in partnership with **Cheshire West and Chester Council** to appoint a **Senior Regulatory Services Officer** to their **Regulatory Services.** **3-6 Month agency contract** with a view to being extended on an ongoing basis. **Location **- Cheshire, CW7 1AH. **Rate of Pay** -...
-
Director, Regulatory
1 month ago
Runcorn, Cheshire, United Kingdom Real Full timeOur client is an established pharmaceutical company looking to add a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide...
-
Director, Regulatory
22 hours ago
Runcorn, Cheshire, United Kingdom Real Full timeOur client is an established pharmaceutical company looking to add a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide...
-
Director, Regulatory
2 weeks ago
Runcorn, Cheshire, United Kingdom Real Staffing Group Full timeOur client is an established pharmaceutical company looking to add a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide...
-
Director, Regulatory
1 day ago
Runcorn, Cheshire, United Kingdom Real Staffing Full timeOur client is an established pharmaceutical company looking to add a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide...
-
Director, Regulatory
1 day ago
Runcorn, Cheshire, United Kingdom Real Staffing Full timeOur client is an established pharmaceutical company looking to add a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide...
-
Regulatory Affairs Engineer
2 weeks ago
Warrington, Cheshire, United Kingdom Risktec Solutions Ltd Full timeTV Rheinland is a leading provider of technical services worldwide. We provide a broad range of testing, inspection and certification services to ensure the safety, reliability and regulatory compliance of engineering assets throughout their lifecycle. As part of the TUV family Risktec Resourcing have been tasked to assist our sister company TUV Rheinland...
-
Personal Tax Senior
2 weeks ago
Northwich, Cheshire, United Kingdom Hays Senior Finance Full timeYour new firm Your new firm are a well known top 100 firm of chartered accountants with offices based across the North West. They have a very strong regional presence in the North West and provide a full range of general practice services. The tax team is a well established function in the practice where they work with a real mixture of clients. Due to...
-
Senior Group Reporting Accountant
2 weeks ago
Warrington, Cheshire, United Kingdom Hays Senior Finance Full timeHays Senior Finance are working with an established global business who are looking to recruit a qualified Senior Group Reporting Accountant. This large and complex business has a large Group office in Runcorn with multiple corporate functions as well as a long-standing manufacturing facility with site finance team. As a Senior Group Reporting Accountant...
-
Senior Director, Commercial Management
1 month ago
Runcorn, Cheshire, United Kingdom Real Full timeOur client is an established pharmaceutical company looking to add a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide...
-
Senior Director, Commercial Management
1 week ago
Runcorn, Cheshire, United Kingdom Real Full timeOur client is an established pharmaceutical company looking to add a Quality Director to head up a Quality department. The Quality Director will promote and integrate quality into every aspect of the business ensuring GMP compliance and meeting the authority's expectation. The role holder will perform all duties required of a Quality Director, provide...
-
In-House Tax Senior
2 weeks ago
Cheshire, United Kingdom Hays Specialist Recruitment Limited Full timeYour new companyThis is a global property development firm who are an industry leader in their field, and are looking to recruit a mixed tax senior for their head office in Alderley Edge. The firm provides modern housing and apartment solutions that cater for a range of demographics across the UK. The firm are ambitious, and are eager to bring in talented...
