Ref: HM43327

Regulatory Assistant Manager – Healthcare Consumer Products (Ref: HM43327)

Sector Others
Type Full-time, Permanent
Location London
Salary (Annual) £40,000 - 70,000 / Year
An international Healthcare Organisation specialising in consumer health products is looking to grow their UK operation and require a Regulatory Assistant Manager to take charge of their new regulatory operations.
Job Purpose:

This position will support in organising Regulatory Affairs of consumer products (including but not limited to various medical devices and pharmaceutical-based products) aimed at the UK market, as well as EU markets.

Also, in order to harmonize the Group activities with the Asian Headquarters and manufacturers, this position, through reporting to the international R&D department, is in charge of medium to long-term Regulatory operations including local systems improvements, local staff training and future business expansion.

Duties and Responsibilities:

1. Improve the regulatory management system with the Regulatory Manager

- Develop and implement a Regulatory Program including policies, procedures (SOPs), insuring that all governmental regulatory regulations including MHRA requirements for products are achieved.
- Prepare, record, and manage documents necessary to establish the system of Regulatory Affairs in order that the Company will have been selling regulatory products sustainably. SOPs of which include:

• The rules to record all information related with Regulatory Affairs
• The rules to maintain our certifications
• The guidelines to address new product developments

2. Accelerate product developments and keep certifications the latest

- Recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for new products based on regulatory expertise with regulations & processes. Especially for:

• High Class Medical devices like Class IIb and III
• Medicinal products
• M&A business from regulatory points of view
• Batch testing of our devices implemented by our own facilities

- In charge of the timely approval and renewal of product licenses, company certificates, through working with Regulatory officials, Notified Body(s) and regulatory consultant(s).

- Deal with audits which are implemented by Notified Body(s) and consumers, which includes supporting factory(s) when audited in order to maintain certificates

- Review technical dossier of products and prepare additional documents where necessary

- Handle post-marketing activities and yearly reporting requirements of company and product licences.

3. Analyse relevant regulatory trends

- Keep updated with regulations and organizational structure and potential changes that will impact the business environment and communicate appropriately to involved or parties

- Maintain a current awareness of the regulatory requirements for the general legislation and guidelines (for instance REACH and Environmental regulations including recycling etc...) in EU

Ideal Candidate:

• Bachelor’s Degree or equivalent qualification within a regulatory discipline
• Experiences in Regulatory Affairs or Certifications as Auditor of Notified Body(s) for CE certificated products
• In depth knowledge of relevant regulatory requirements
• MDR transition’s experiences desirable
• Strong computer skills including Microsoft Office and Databases.
• Must be able to travel
Updated: 25 days ago
Ref: HM43327