Description
New Year, New RoleThe new year begins with two fantastic new Regulatory opportunities...
A Medical Device specialist with over 26 years in the market have introduced two exciting new roles to coincide and integrate with their busy and vibrant Regulatory departments.
One of two important roles as Senior Regulatory Officer is critical to the overall business strategy objectives of the company, with preparation, Submission and approval of Regulatory Submissions a key factor of the role in addition to keeping abreast of regulatory standards and requirements across the company.
You will be playing a pivotal role the development of regulatory strategies for the exciting new product range, ensuring smooth development and launch to the market.
As a like minded professional wanting to progress to the next stage in their career, you will grow within the company as part of a dynamic yet family orientated workplace striving towards further successful growth whilst maintaining and building on world class reputation and compliance.
Once you've started you be the main person responsible for:
- The preparation of Design Dossiers, Ensuring regulatory requirements for all markets are met and ensuring Design Control processes are followed.
- Liaising with regulatory authorities as necessary during the regulatory submission process.
- Creating and implementing the use of and maintaining an Authorised Shipment Database, ensuring a product is only shipped to countries where there is regulatory approval to do so.
- Ensuring requirements for vigilance and Field Safety Corrective Action are met for all markets where products are sold
- Supporting the Quality Assurance Manager in ensuring that the company is audit ready including the participation of Quality audits as required to discuss regulatory issues.
- You will have a good understanding of US, EU and and other international regulatory requirements, have strong interpersonal and communication skills with the ability and readiness to interact across the board at all levels.
- You will also have the ability to work independently as well as part of a team, whilst building interpersonal relationships and influencing consensus across functional groups.
Other requirements:
- BS degree, 3+ years minimum experience in medical device Regulatory Affairs.
To find out more about this opportunity, please call Marvin Trenchfield at Real Staffing on or Apply Directly to this advert.
Applications are coming in thick and fast so please contact me as soon as possible to avoid disappointment.
Please Note: EU citizenship required / Medical Device Regulatory Experience is essential.