Regulatory Specialist and Senior Specialist

1 week ago

Crawley West Sussex, United Kingdom Welland Medical Ltd Full time

Welland Medical is the part of Clinimed Holdings Limited group, a leading name in Healthcare and Medical Equipment industry. Clinimed Holdings Limited is a group of companies founded in 1982 following the acquisition and formation of number of additional companies within the group.

Welland Medical brings to market the best and most innovative products that enhance the lives of people living with a stoma across the world. Investing in the most talented people, collaborating to create world-class, ground-breaking products and services devoted to improving peoples’ lives. Our reputation is based on a tradition of improvement, ethical leadership, and total commitment to quality and safety.

We're proud of our company culture, which is built on a foundation of collaboration, teamwork, and open communication. Contributory Pension Scheme (4% Employee and 5% Employer Contribution, increasing to 10% with service)
Medical Cash Back Plan
Life Assurance (4 x Annual Gross)
Annual Performance Bonus
Annual Pay Review
Cycle to Work Scheme
Employee Referral Scheme
Discounts on Selected Products and Services
Employee Assistance Programme – Health and Wellbeing
Annual Leaves - 25 Days Per Year Rising to 27 Days After 5 Years Service In Addition to Bank Holidays and An Extra Company Day

As a Senior Regulatory Affairs (RA) Specialist, you will be pivotal in supporting the business by developing regulatory strategies for new product development and registrations. You will manage the upkeep of all regulatory documentation and ensure that regulatory and standard changes are monitored and implemented as needed. Lead a regulatory team of two, ensuring compliance with all relevant regulations and standards across the business.
Collaborate with regulatory authorities to achieve successful product registrations.
Develop and implement regulatory strategies for New Product Development (NPD) projects, from inception through Post-Market Surveillance, to ensure ongoing compliance and support product launches.
Oversee the maintenance of all regulatory documentation, including Clinical Evaluation Reports (CER), technical files, dossiers, and other regulatory submissions.
Provide regulatory support for sales and commercial activities, addressing customer and market authority inquiries and managing expectations.
Lead interactions with Notified Bodies on regulatory affairs (RA) matters.
Support all communications with regulatory authorities.
Lead regulatory transition projects and other significant regulatory initiatives.
Lead submission strategies for NPD projects and offer guidance on R&D product development.
Oversee regulatory decisions related to change control, assessing implications, approving or rejecting as appropriate, and maintaining accurate records of actions taken.
Support Quality Assurance (QA) in maintaining the Quality Management System (QMS) and Good Manufacturing Practice (GMP) certification, ensuring regulatory compliance across the organization.
Participate in auditing processes, providing regulatory guidance, and engaging in Notified Body audits.
Support vigilance reporting and Field Safety Corrective Actions (FSCA), liaising with regulatory authorities as needed.
Monitor and review changes in regulations and standards, assessing their impact on the business.
Create and maintain procedures to ensure ongoing regulatory compliance.
Advise and train colleagues on regulatory requirements, providing support to ensure full understanding and adherence.
Bachelor’s degree (or equivalent) in a scientific, engineering, legal, or regulatory discipline.
Previous experience in a Quality Assurance or Regulatory Affairs role within a medical device manufacturer, Notified Body, consultancy, or regulatory agency.
Proven experience with medical device technical files and EU MDD/MDR requirements.
In-depth understanding of the relationship between international standards and regulatory requirements, including the role of harmonized standards.
Current specialist knowledge of medical device regulatory requirements in the EU and UK.
Experience working within a Quality Management System certified to EN ISO 13485.
Additional qualifications in the field of medical device regulatory affairs.
Demonstrable experience as part of a project team implementing significant regulatory transitions (e.g., Experience working with non-EU medical device regulations.
Project management experience.

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