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Regulatory Affairs Jobs

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Quality Assurance / Regulatory Affairs Manager
  • Job type: Permanent
  • Location: Bertschikon b. Attikon
  • Salary: Competitive
  • Description My client is looking for a Quality Assurance / Regulatory Affairs Manager to work within my clients Quality department in Attikon, Switzerland. This is a very...
Senior Regulatory Affairs Manager (Medical Devices)
  • Job type: Permanent
  • Location: Brussels
  • Salary: €90000 - €100000 per annum, Benefits: 15%
  • Description My client enables healthier lives, everywhere, every day, by bringing to market innovative diagnostic, medical imaging, surgical and medical aesthetic products.  They are interested in...

Regulatory Affairs specialists are responsible for monitoring internal practices, developing internal regulatory policies to ensure that an organization’s operations are compliant with government regulations, and coordinating with various regulatory agencies. This role can often be found in sectors such a medicine, pharmaceuticals, and food production, given the need to adhere to strict health and safety regulations within these industries.

Regulatory Affairs Employment Outlook and Salary  
In the United States, the average salary for a Regulatory Affairs Director is $130,959, with a range of $85,706 - $206,598 per annum. In the UK, the average salary is £80,513, with a range of £62,284 - £137,925 per annum.  Salaries vary based upon skills, educational background, industry knowledge and experience.

Regulatory professionals with clinical training are currently in high demand, with a shortage of qualified candidates for more senior positions. 

Typical Job Description
Regulatory Affairs professionals act as a link between regulatory bodies and companies, overseeing a product as it obtains government regulatory approval, and developing various procedures to ensure proper regulatory compliance within an organization. This role is usually found in highly regulated sectors, such as pharmaceuticals, medical device manufacturers, energy and banking.

The role will likely include:

  • Plan, oversee, and undertake regulatory inspections and product trials 
  • Offer relevant advice on company practices, policies and systems 
  • Analyze trial data through a range of specialist software
  • Keep up to date with developments in legislation and regulatory guidelines
  • Advise on regulations affecting both research and production
  • Negotiate and liaise with regulatory authorities
  • Gather, organize, evaluate, collate and manage key information
  • Ensure that quality standards are continually met

Key Skills & Qualifications  
Regulatory Affairs Directors must possess strong managerial skills and should have strong knowledge of all rules and regulations relevant to the industry, remaining up to date on any regulatory developments as well as keeping ahead of trends within the industry. 
A bachelor's or master’s degree in business or in a relevant field as well as experience in a regulatory capacity are required and many directors of regulatory affairs also hold a higher degree or qualification in addition to these. 

Some key job skills are:

  • Natural ability to solve complex problems, reviewing related information in order to evaluate options and implement solutions
  • Critical thinking skills, with the ability to use reasoning and logic to inform critical decisions 
  • Excellent judgment alongside strong teaching and negotiation skills  
  • Ability to measure a system’s performance and take appropriate actions to correct or improve performance when necessary