Careers at Clinisupplies

Head of Regulatory Affairs

Head office, Harrow

Area: Sales

Reports to: CEO

JOB PURPOSE

Senior Regulatory Affairs Specialist required to lead an experienced regulatory department at a time of growth. The company already have a long history, strong reputation and market presence in Europe and international markets and are looking to grow significantly through new product introduction and registrations into new countries.

The role of Senior Regulatory Affairs Specialist will be key in project managing registrations into territories such as Latin American Markets, Asia-pacific, Middle-East & North Africa and European markets.

As a Regulatory Affairs Specialist, the primary responsibilities are to ensure regulatory compliance of defined Healthium products globally, drive regulatory processes and activities (such as change control) and continue to develop strong working relationships with internal and external customers. You will be responsible for the management of global and regional regulatory projects, including, but not exclusively, product life cycle and regulatory processes.

More specifically

  • You will create, develop and maintain high quality regulatory compliant documentation for all stated markets and product categories.
  • You will need to demonstrate the ability to build relationships and negotiate with relevant regulatory bodies on matters related to compliance of existing products and products undergoing development.
  • For medical device products under development you will liaise with Project Development teams to ensure regional RA requirements are included in the project plan and prepare the pre-marketing documentation e.g. for CE marking according to the agreed timeline

Qualification/Experience

  • Life Science Degree or equivalent
  • Experience as a Regulatory/Quality Specialist in medical devices
  • Hands on experience of creating documentation compliant with FDA CFR 820 and EC Medical Devices Directive 93/42/EEC
  • Knowledge of compliance with key international standards such as ISO 13485 and ISO 14971

We are looking for an individual who can create new and innovative ways of doing things, demonstrates flexibility, open-mindedness, and adaptability to a rapidly changing environment.

Regulatory Affairs Responsibilities:

  • Generate product registration documentation and report directly into the group CEO and COO on the progress of registrations with internal colleagues within: R&D, Engineering, Technical Publications, Clinical, Sales & Marketing and Product Management.
  • Coordinate with international affiliates, distributors and competent authorities to ensure timely licence approvals.
  • Keep up to date with and prepare briefing summaries on new regulations and advice on regulations where applicable.

Knowledge/Skills/Experience:

  • Considerable experience of working with international medical device regulations.
  • Thorough working knowledge of international medical device regulations and pre-market registration requirements.
  • Ability to communicate with and contribute within on cross-functional teams.
  • Must be able to synthesize technical and clinical information to write clear, understandable licence application documents.

Salary estimate 45k – 50k plus bonus

Can do Will do attitude

Goes the extra mile and exceeds boundaries whenever possible – understands the ability of the individual to change their future

Values

Passion - To strive to better understand people’s needs.

Respect - To always act with honesty and integrity.

Ambition - To innovate & make a real difference in healthcare.

CliniSupplies is dedicated to the continuous development of our employees and offer excellent career prospects for the strong candidate. We offer an attractive benefits package including 26 days holiday (increasing with service) plus bank holidays, pension, profit related pay, life assurance and personal accident insurance.

Clinisupplies Limited is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.

If you are interested in this position, please forward your CV to hr@clinisupplies.co.uk

Please note that in addition to the interviews there will be assessments as part of our recruitment and selection process