Senior Regulatory Affairs Associate Opportunity
Cure Talent is partnering with a reputable Medical Device company to find a skilled Senior Regulatory Affairs Associate for their site in West Yorkshire. Due to their continued growth, this role offers an exciting chance to contribute to the company's success.
This Senior Regulatory Affairs Associate will collaborate closely with the Regulatory Affairs Manager to ensure regulatory compliance across the business, creating, reviewing and updating Technical Files, PMS and conducting audits.
To excel in this position, you should be an experienced Regulatory Affairs professional with a strong background in the Medical Device sector. Key areas of expertise include Technical File management, Post-Market Surveillance, and MDD/MDR compliance.
Key Responsibilities:
* Ensuring MDD & MDR compliance throughout all business activities
* Developing, reviewing, and updating Technical Files
* Managing Post Market Surveillance activities
* Maintaining regulatory compliance according to ISO 13485 standards
* Conducting internal audits to guarantee compliance
Requirements:
* Demonstrated experience in a RA role within the Medical Device sector
* Familiarity with Technical File creation and management or similar experience
* Proven knowledge of Post Marketing Surveillance practices
* Expertise in MDD, MDR, and ISO 13485 regulations
We are seeking a talented Regulatory Affairs professional who can make a meaningful contribution to our client's continued success. If you possess the necessary skills and qualifications, we encourage you to apply for this opportunity.
The salary range for this position is estimated at £50,000 - £65,000 per annum, depending on experience and qualifications. This figure takes into account the location, industry standards, and the level of expertise required for the role.