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Senior Regulatory Affairs Specialist
2 months ago
About Us:
Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match.
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. We are passionate about making a difference in the world. 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. Our employees are passionate, driven, and committed to delivering the best possible results for our clients.
If you have passion for learning and want to build a career with a company that values its employees and is dedicated to making a positive impact in the world, we encourage you to apply.
Benefits:
- 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
- Free Yearly Flu Vaccination
- 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
About Job:
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. Additionally, you will step in for the QARA Manager on all RA-related matters when required.
Main Duties & Responsibilities:
- 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.
- Ensure that Instructions for Use (IFUs), labelling, marketing materials, and technical documentation comply with relevant regulations and standards.
- Create and maintain procedures to ensure ongoing regulatory compliance.
- Advise and train colleagues on regulatory requirements, providing support to ensure full understanding and adherence.
- Manage, support, and mentor the RA team.
About You:
An ideal candidate for this position will have the following experience, skills, and attributes. Please note that these competencies are not ranked in order of priority. Following criteria will be used in selecting a candidate.
Essential:
- 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.
- Demonstrable experience working with EU MDD/MDR Class I and/or Class II devices.
- 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.
- Comprehensive knowledge of EN ISO 13485.
- Current specialist knowledge of medical device regulatory requirements in the EU and UK.
- Familiarity with EN ISO 14971.
- Experience working within a Quality Management System certified to EN ISO 13485.
- Strong leadership skills with the ability to independently take initiative and complete tasks.
- Exceptional attention to detail, with a clear understanding of the broader implications of actions and decisions.
- Excellent written and verbal communication skills, effective across all levels of the organization and with external contacts.
- Ability to manage competing priorities and workloads to meet deadlines.
Desirable:
- Additional qualifications in the field of medical device regulatory affairs.
- Demonstrable experience as part of a project team implementing significant regulatory transitions (e.g., EU MDD to EU MDR).
- Experience working with non-EU medical device regulations.
- Detailed knowledge of EN ISO 15223-1.
- Project management experience.
- Experience working within EN ISO 14971, EN ISO 15223, and EN ISO 20417.
