Regulatory Affairs Assistant

JR United Kingdom; Winsford; On-site; GBP 35,000 - 60,000; Full time

Job summary

A leading company in biosurgical products is seeking a Regulatory Affairs Specialist to support the development of new products and ensure compliance with international regulations. The role involves generating documentation for regulatory submissions and maintaining compliance for existing devices. Ideal candidates will have a science-based degree, strong communication skills, and relevant experience in the medical device industry.

Qualifications

• Relevant medical device experience preferred.
• Proficiency in written and spoken English.
• Awareness of regulatory requirements is desirable.

Responsibilities

• Generate and submit regulatory-compliant documentation for global markets.
• Maintain registrations and ensure compliance with medical device regulations.
• Participate in new product developments and regulatory strategy.

Skills

Communication

Organizational skills

Analytical skills

Teamwork

Education

Science-based degree or equivalent

Tools

Microsoft Office suite

Job description

Job Description

AMS is a world-leading independent developer and manufacturer of innovative tissue-healing technology, focused on quality outcomes for patients and value for payers. AMS offers a wide range of surgical products including tissue adhesives, sutures, haemostats, internal fixation devices, and internal sealants, marketed under various brands. The company also supplies wound care dressings through its ActivHeal brand and white label products. Established in 1991, AMS has over 1,500 employees and operates globally with manufacturing in multiple countries and sales via regional partners and direct sales forces. For more information, visit www.admedsol.com.

AMS values diversity and provides equal employment opportunities, encouraging applicants from all backgrounds without discrimination.

Role Purpose

This role supports the development of new Biosurgical products and the creation of submissions in Europe, the USA, and other international markets, ensuring compliance with regulatory requirements. It also involves maintaining compliance of existing devices in the Biosurgicals category.

Key Responsibilities

1. Generate and submit high-quality, regulatory-compliant documentation for all product classes across global markets to secure timely approvals.
2. Maintain current registrations, licenses, regulatory certifications, and submissions to ensure ongoing compliance with medical device regulations worldwide.
3. Manage Regulatory Technical Documentation.
4. Participate as a core team member in new product developments and major extensions, ensuring regulatory activities are integrated into project plans.
5. Develop regulatory strategy documents for new products.
6. Support regulatory review and approval of compliance records such as design control documentation, labelling, marketing literature, change controls, and risk management.
7. Assess and submit changes to devices, manufacturing processes, and quality systems to regulatory authorities globally.
8. Support and participate in company quality system audits.
9. Monitor industry-wide regulatory activities.
10. Continuously improve processes for generating and maintaining regulatory documentation.
11. Support post-market surveillance activities, including vigilance reporting, customer feedback, and clinical trend analysis.

Candidate Profile

1. Science-based degree or equivalent; relevant medical device experience preferred.
2. Proficiency in written and spoken English.
3. Awareness of regulatory requirements is desirable.
4. Experience with key market approval processes in Europe and the USA is advantageous.
5. Excellent communication skills, both written and verbal.
6. Strong organizational skills, including responsiveness and teamwork.
7. Ability to work under pressure and meet deadlines.
8. Strong analytical skills.
9. Constructive influence and challenge skills to promote improvements.
10. Proficiency in IT tools, especially Microsoft Office suite.