Medical devices businesses are increasingly being subjected to sanctions by a variety of regulators; there may be serious outcomes arising from regulatory inspections that have to be resolved.
To maintain a compliant operation many businesses are hiring teams to carry out regulatory remediation projects to identify and resolve issues and remove sanctions, leading to a high demand for consultants with the knowledge and capability to implement new and updated regulations.
NES Fircroft’s Life Science division works with a pool of professionals with experience and understanding of current regulations, directives, guidelines and laws affecting pharmaceutical and manufacturers in FDA, EU and other regulatory markets who we assign to work on client projects.
Market expertise
We understand that operating under the oversight of the FDA and other global regulatory bodies puts a great deal of pressure onto your processes; any misstep can result in severe consequences such as product seizures, recalls or even company closure.
Our services enable clients to deliver on follow-up commitments and projects quickly, to remediate or realign quality management systems and stay ahead of regulatory requirements to avoid costly oversights.
Our Expertise:
Our candidates will develop and implement internal processes to ensure that your company’s systems run seamlessly through writing and executing standard operating procedures and performing batch record reviews; developing and implementing quality systems; planning and resolving corrective and preventative actions (CAPAs) and evaluating / executing quality control.
We have access to engineers across software, mechanical and electrical backgrounds who are responsible for designing, developing, testing, and deploying products, systems, applications, and equipment. The consultants we source also have expertise validating equipment, processes, software, and cleaning systems.
The experts we place will conduct GMP/ GCP auditing, perform 483 observations and remediation, provide consent decree resolution, and coordinate regulatory filings (IND, NDA, 510k, and PMA), as well as complaint handling and medical device reporting.
We work alongside FDA regulated companies that are researching and developing new products and providing them with the expertise needed to get their drugs, biologics or devices to market. Our solutions cover strategic areas which include: Clinical Research, Biostatistics, Statistical Programming, Data Management, Pharmacovigilance / Drug Safety and Regulatory Affairs.
Through our comprehensive recruitment methodology we assist understaffed Life Science companies by providing remediation specialists who will quickly assimilate to your working environment, including specialists across:
- Biometrics
- Clinical Operations
- Design Engineers
- Engineering
- Health Economics / Market Access
- Human Factor Specialists
- Regulatory Affairs
- Pharmacovigilance Medical Affairs
- Quality
- Scientific / Research
NES Fircroft gives you access to the best Medical Devices candidates
Our understanding of the Medical Devices market coupled with our broad European candidate networks means we can assist understaffed Life Science companies by providing remediation specialists who will quickly assimilate to the working environment:
Our talent networks keep track of the ever-changing legislation and have an in-depth understanding of all applicable directives, guidelines and laws affecting pharmaceutical businesses and manufacturers in FDA, EU and other regulatory markets.
Our global network of compliance and quality consultants have a breadth of experience in applying a clear-cut approach to systematically tackle the issue, collating and evaluating all data to make informed decisions about your business.
Our quality remediation specialists are able to put an effective CAPA system in place, identifying the root cause of the problem and proposing actions to prevent recurrence, facilitating the transparency that regulatory authorities expect.
We will provide specialists with experience in change management, including those with a blend of skills across technology, strategy and those with the soft skills required to keep all parts of your operation in the loop and running smoothly.
Responding to regulatory body enforced changes can be a stressful time. Our candidates will keep a level head and employ an approachable, tactful attitude to build cross-departmental rapport in an effort to liaise effectively with all affected parties and resolve conflict.
Our Recruitment Services
Case Study
Case Study
Supplying regulatory affairs specialists & broadening original scope through exceptional delivery
Our client is a medical device manufacturer, developing cardiovascular products for minimally invasive procedures. They have operations across Ireland, Denmark, Switzerland and the USA.
The client sought to hire a position of:
- Regulatory Affairs Specialist
(contract basis)
The client's hiring challenges
Talent pool: The specialised nature of the client’s work means there is only a small eligible talent pool containing professionals with experience gained from a matching background.
Legality: Mitigating the varying legislation involved across their broad geographic remit had proven to be highly complex.
Timings: Before doing business with an agency partner the client must undertake highly comprehensive audits which adds a significant delay to the recruitment drive - by the time NES Fircroft was deemed a suitable supplier, time was of the essence.
Our compliance and financial strength were instrumental in securing the client
- NES received certification to the international standard for Quality Management in 1994 and in 2018 we successfully achieved transition to the new ISO9001:2015.
- We appointed a specialist Regulatory Affairs Recruitment Consultant in order to fulfil the scope who delivered a prospective candidate list within just 3 days from receiving the brief.
- Our Commercial, Legal and Assignment Support professionals diligently undertook all required paperwork in the onboarding process.
The Results of our Recruitment Support
Placements
Through positive feedback from the Hiring Manager the initial scope expanded to placing 3 more contractors across 2 teams in different business units in Ireland.
100% Fill Rate
Our 100% fill rate led to NES Fircroft being signed as the client’s Regulatory Affairs recruitment partner on an exclusive basis.
Other Life Sciences markets supported
Clinical Research
Scientific
Regulatory Affairs
Diagnostics
Digital Health
Biometrics
Quality Assurance
Manufacturing & Tech Ops
Commercial & Sales
Biotechnology & Specialty Pharma
