Senior Technical Regulatory Affairs Associate

Adecco; Warrington; On-site; GBP 45,000 - 50,000; Full time

Job description

Senior Technical Regulatory Affairs Associate

Job Title: Senior Technical Regulatory Affairs Associate

Industry: Medical Devices

Location: Cheshire

Position Type: 12 Month Fixed Term Contract (Potential for Perm)

About The Company

A world-leading developer and manufacturer of tissue-healing technology, this company focuses on quality patient outcomes and value for payers. Its surgical products include tissue adhesives, sutures, haemostats, fixation devices, and sealants. Since 2019, it has acquired seven companies specialising in internal sealants, biomaterials, wound care, and surgical implants. Products are manufactured across Europe, Asia, and Israel, with global distribution through partners and direct sales teams. The company operates R&D hubs in the UK, Ireland, Germany, France, and Israel and employs over 1,500 people.

Job Description

Overview

In this role, you will be responsible for supporting the regulatory affairs function within the medical device industry, leveraging your strong scientific background and hands-on experience with DHF (Design History File) maintenance, risk management processes, and technical regulatory submissions. You will work collaboratively with cross-functional teams to ensure compliance with global regulatory requirements, providing critical input for technical documentation, risk management, and change assessments. Your expertise will help facilitate the progression of new products and modifications through the regulatory lifecycle, ensuring timely and successful regulatory submissions.

Key Responsibilities

1. DHF Maintenance: Oversee and manage the maintenance of the Design History File (DHF) to ensure it is complete, accurate, and up to date in accordance with regulatory requirements.
2. Risk Management: Lead and drive the risk management process (ISO 14971), identifying, assessing, and mitigating potential risks throughout the product lifecycle.
3. Verification & Validation: Support and coordinate the necessary verification and validation activities needed to address changes and ensure regulatory compliance.
4. Technical Regulatory Submissions: Respond to global regulatory questions, particularly related to technical aspects of medical device submissions.
5. Audit Support: Provide technical expertise during audits and inspections, answering complex regulatory questions and ensuring all documentation meets regulatory expectations.
6. Biological Safety: Apply knowledge of ISO 10993 series standards to address biological safety requirements for medical devices.
7. Change Assessments: Conduct change assessments for design and manufacturing processes, ensuring that any modifications meet regulatory and compliance requirements.
8. Collaboration: Work closely with cross-functional teams (engineering, quality assurance, product development) to ensure that products meet regulatory requirements and technical standards.

Your Skills and Attributes

Education: Bachelor's degree in a scientific or technical discipline (e.g., Biology, Engineering, Life Sciences). Advanced degrees (Master's, PhD) are a plus.
Experience:

1. 5+ years of experience in a technical role within the medical device industry, with a focus on regulatory affairs, product development, or quality assurance.
2. Hands-on experience with DHF maintenance and leading risk management processes (ISO 14971).
3. Experience in addressing global regulatory submission questions and supporting technical regulatory documentation.
4. Knowledge and practical experience with ISO 10993 series for biological safety and change assessments.
5. Audit experience, ideally with the ability to answer complex technical regulatory questions during inspections.

Skills:

1. Strong understanding of the medical device regulatory landscape and international standards.
2. Excellent problem-solving, communication, and collaboration skills.
3. Ability to manage multiple tasks and deadlines in a fast-paced environment.
4. Detail-oriented with a focus on accuracy and compliance.

Preferred Skills:

1. Experience with additional quality management systems, standards (e.g., ISO 13485), and product lifecycle management.
2. Experience with submissions to global regulatory agencies (e.g., FDA, EMA, TGA).

Salary:
£45,000 - £50,000 per annum

How to Apply:
Apply now by submitting your CV below, alternatively you can send your CV to (url removed). Please include "Senior Technical Regulatory Affairs Associate" in the subject line.