Competitive Salary and bonus opportunity
This role comes to market from a global leader in the design and manufacture of electromechanical products as well as class I and II medical devices. With the business continuing to invest in the development of next generation technology you will be helping to ensure their new products are successfully registered and compliant for sale in multiple regions around the world.
Joining as Regulatory Affairs Manager you will be a key liaison between R&D, Business Development, and Product Management working to ensure both new and existing products meet the regulatory requirements for all regions the products are available for sale. This will include ensuring the correct registration, licensing, marketing and legal compliance of both products and the manufacturing sites themselves.
Further responsibilities will include:
* Acting as company representative when communicating with notified bodies and certification authorities internationally
* Identifying, communicating, and Coordinating regulatory changes within the business to ensure compliance is maintained and there is no negative impact.
* Liaising with QA/RA management throughout the global business sharing best practice and encouraging collaboration
* Ensure subject matter experts within the business have access to current regulatory standards and requirements.
* Generate RA registration plans for New products, product changes and renewals
* Maintain all technical information and documentation such as the deceleration of Conformity, Device Master records and other technical files required as part of CE marking and registration activities
* Support product registrations in all international markets where the company markets its products with a particular focus on the US and MDSAP markets. This will include 510(k) submissions and EU CE marking.
To carry out this business-critical role they are seeking an experienced Regulatory affair’s professional with 5-10 years + in industry. Further skills/experience required includes:
* Degree certified in engineering or a scientific subject such as biomedical science, chemistry or pharmacy
* 5 to 10 years industry experience within regulatory affairs, quality, or R&D within the medical device sector
* A track record of experience in product registration, medical device file and technical compliance activities
* A strong understanding of EU MDD / MDR, ISO13485, ISO60601, FDA QSR, JPAL and MDSAP requirements
* An understanding of active medical devices, including risk assessment, clinical experience, post-market surveillance and quality compliance.
Offering a great work environment this exciting position comes from a business that really values its people. Company benefits include a free coach service from their local train stations increasing access from the local area, central and east London as well as an onsite subsidised canteen and an onsite nursery. Employee benefits include double matched contributory pension to 12% and private healthcare after your first year.
Please note the employer has implemented a number of measures to make sure their site is Covid Safe and is also currently offering employees the choice to work from home or onsite as they feel comfortable with this being continuously monitored by the business in line with government advice. Long term the business is reviewing their work from home policy with greater flexibility expected to stay in place. Whilst this role is not open to complete remote working, the business are happy to consider applications from those that would require the flexibility to partially work from home.
To apply please submit your CV for consideration
Product Quality Assurance