Quality and Regulatory Affairs Manager at SASMAR Pharmaceuticals - Legal jobs in Malta - September 2019
SASMAR Pharmaceuticals

Quality and Regulatory Affairs Manager at SASMAR Pharmaceuticals

Central Malta

Regulatory Compliance
Posted date 26/08/2019 |
Closing date 25/09/2019
Full Time Experienced, Management

Sasmar Pharmaceuticals in Malta is looking to recruit a reliable Quality & Regulatory Affairs Manager to take control of our global regulatory medical devices compliance and internal quality management system.

What you will do:
You will combine your knowledge of scientific, legal and business issues to ensure our products, which are developed, manufactured or distributed by a wide range of companies, meet the required legislation. As a crucial link between SASMAR, its products and regulatory authorities (including U.S FDA), you will ensure the appropriate licensing, marketing and legal compliance of our products to ensure quality, safety and efficacy.

You will maintain accurate records, write clear, accessible product labels and provide strategic advice to senior management throughout the development of new products

Liaising with our network of distribution partners worldwide your ability to communicate with different cultures, analyse and filter document requests to prepare and accelerate regulatory submission approvals. You have excellent knowledge of ISO 13481 / ISO 9001 quality management systems and be able to constantly improve efficiency through policies and procedures.

Your tasks include:

  • Gathering, evaluating, organising and managing information in a variety of formats;
  • Ensuring compliance with regulations;
  • Maintaining familiarity with company product ranges;
  • Planning, undertaking and overseeing regulatory inspections;
  • Keeping up to date with changes in regulatory legislation and guidelines;
  • Offering advice about company policies, practices and systems;
  • Obtaining marketing permissions;
  • Outlining requirements for labelling, storage and packaging;
  • Liaising and negotiating with global regulatory authorities;
  • Providing advice about regulations to manufacturers/scientists;
  • Writing comprehensible, user-friendly, clear product information leaflets and labels;
  • Ensuring that quality standards are met and submissions meet strict deadlines;
  • Preparing documentation.

Who you are:

  • You hold a relevant medical or scientific degree, and have a minimum of 2 years of regulatory affairs experience;
  • Knowledge of, and experience with both Class I and Class II (non-sterile) Medical Device registration processes;
  • Ability to maintain confidentiality;
  • Ability to comply with standard practices, regulations and statutes;
  • Excellent written and oral communication skills in English & French;
  • Superior time management and interpersonal skills, the ability to handle multiple projects at once and work with minimal direction.

This position will be located in our new Malta HQ.

Applicants applying must be living in Malta and have a valid work permit. 

SASMAR Pharmaceuticals:
Who we are We are globally minded entrepreneurs focused on leading the way in consumer health. Our personal lubricants help couples in more than 70 countries internationally connect with each other better and with our Conceive Plus brand - we are doing a great job increasing the fertility rate too!  Remaining true to our founding purpose to provide quality personal care products that benefit the lives of consumers.  
What we do - today you'll find our products in more than 70 countries globally in hospitals, supermarkets, pharmacies, drugstores and online. As the need for quality OTC (over-the-counter) pharmaceutical products grow, so do we.

Kindly submit your application directly to us using the 'Apply Now' button.


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