Title: Head of Regulatory Affairs, Person Responsible for Regulatory Compliance (PRRC)
Reports to: CEO
Based at: Farboud Innovation Park, Newmarket
Unisurge International Ltd are a leading manufacturer and supplier of practitioner-specified procedure packs (CPT), dressing packs, medical disposable, PPE and theatre products to healthcare professionals.
We are transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR), so this is a key moment in our company’s history from a Regulatory Affairs perspective.
Responsibilities:
For Regulatory Affairs activities across all sites. Accountable for ensuring compliance to the appropriate regulatory standards (ISO13485, Medical directive 93/42/EEC, cGMP and associated standards) with the support of relevant teams.
Specific Roles and Responsibilities:
* Responsible for all matters related to Regulatory Affairs across all sites and associated personnel to ensure that the business operates to ISO13485, ISO11135 under the MDD 93/42/EEC including an understanding of the process of moving from the MDD to the MDR (Article 120).
* Keeps up to date with the regulatory requirements and international standards (ISO 13485, 11135 etc).
* Responsible for maintaining appropriate licenses so that operations can continue across all sites, upholding compliance.
* Ensures technical documentation including Medical Device files, and EU Declaration of Conformity are correct and kept up to date.
* Ensures Post market surveillance obligations are complied with in accordance with article 10 (10).
* Responsible for the reporting obligations of Vigilance and Implementing Acts, referred to in articles 87 and 91.
* Appoints and has at all times at their disposal an Authorised Representative that must have either a diploma, a degree or equivalent qualification or minimum of 4 years’ experience in Regulatory affairs or QMS related to Medical devices.
* Provide relevant training to staff to increase regulatory awareness.
* Working with department managers to ensure that the Quality Management System is kept updated and is fit for purpose within the environment in which the company operates.
* Represent the objectives of Regulatory Affairs Department on behalf of the company.
* Act as department lead and contact for auditors from Regulatory bodies and ensuring that any issues are addressed by the operations team to agreed timeframes.
* Contributes towards Continuous Improvement (CI) initiatives using appropriate tools and principles, e.g. 5 Whys/8D To promote the use of CI tools and principles within the area. To help develop site employees in the CI concepts and progress improvements.
* Maintain familiarity with company product ranges.
* Compile technical files and design dossiers, review and assess technical documentation and determine compliance with the MDD / MDR (where applicable).
* Interpret general business objectives and effectively report information to senior management and relevant departments.
* Review and approve product labelling. Approve and oversee product IFUs and other required product labelling in line with relevant EU & international requirements (MDR).
* Support “virtual manufacturer” (Own Brand) suppliers and liaise with EU Competent Authorities and Government Bodies (e.g. Department of Health) as necessary.
* In addition to the required technical documentation, supplies samples, packaging, manufacturing site quality system certificates, and certificates of free sale, etc. for product registrations.
* Undertakes other administrative tasks to support CE marking and regional registrations. Oversees all registration processes (FDA, SFDA, NBs, Cert bodies, MHRA etc.).
* Demonstrate a degree of professionalism to internal and external business associates that reflect positively on Unisurge International Ltd., the individual needs to convey a trustworthy, credible, and reliable image always.
* Oversee, facilitate and chair the Management review meeting, to senior managers at agreed increments (e.g. bi-annual).
* Oversee and deliver audits from Notified bodies by way of agreeing dates, venues, subsistence, accommodation where necessary through support from the finance department.
* Responsible for the output of the Laboratories – facilitate, oversee, the day to day running, ensuring all checks, samples, are completed, monitored and results are recorded. Review, update and generate Laboratory validation protocols and Laboratory standards and operating procedures, ensuring compliance.
* Responsible for the output of the ETO steriliser and oversees its compliance and safe function.
Principal Relationships:
* Accountable to – Chief Executive Officer and The Board
* Direct reports – Authorised Representative/Technical Specialist, and others (to be agreed e.g. Microbiologist).
* Responsible for - Regulatory Affairs.
* Internal - Works closely with Quality Assurance, Quality Control, all Senior Managers (Contracts, Customer Services, Purchasing, Operations, facilities, Health and Safety, Environment)
* External – Maintains external contacts with customers (where applicable) and suppliers, and others (e.g. Notified Body, MHRA).
Key knowledge and skills:
* A broad in-depth knowledge of Regulatory Affairs and CE certification including UKCA.
* Good organisational skills.
* Good time management skills.
* Self-sufficient to complete tasks within deadlines with minimal supervision.
* Attention to detail.
* Team player.
* In depth understanding of ISO 13485 requirements and EU MDD & MDR.
* Ability to read and understand technical material.
* Excellent written and verbal communication skills.
* Computer literate, with intermediate skills in the use of Word, Excel and Outlook, and some knowledge of relational database systems, e.g. Microsoft Dynamics/Navision.
* Experienced at reviewing and approving product labelling.
* Flexible and able to self-manage multiple priorities.
* Able to work effectively in multinational/multicultural environments.
* Flexibility to work across the UK sites.
Education and Experience:
Essential
* A diploma, certificate or other evidence of formal qualification, awarded on completion of a University Degree or of a course of study. Law, Medicine, Pharmacy, Engineering or other relevant scientific discipline and at least one year of professional experience in Regulatory Affairs or QMS related to Regulatory Affairs. Or minimum of 4 years’ experience in Regulatory Affairs or in Quality Management Systems relating to Medical Devices.
* ISO13485 Internal Auditor experience.
* Extremely strong leadership with a quality compliance background. Must have experience of operating within ISO13485 and the medical device directive (93/42/EEC) or Medical Device Regulatory.
* Proven experience of effectively leading a team.
* Relevant regulatory experience which ideally includes the compilation of technical files and design dossiers.
* Ability to review and assess technical documentation and determine compliance within the Medical Devices Directive.
* Minimum 4 years’ experience in Regulatory Affairs or QMS related to medical devices.
* Experience / Knowledge of the MDR and can assume the role of “Person Responsible for Regulatory Compliance” (PRRC) as per Article 15 of the MDR.
* Understands the principles of Sterilisation and is familiar with ISO 11135.
Desirable
* Affiliation with TOPRA / TOPRA recognised qualification, e.g. MSc in Medical Devices.
* Good understanding of Lean Manufacturing and application of suitable techniques, e.g. 5 Whys / 8 Ds.
* Experience as an audit lead with ability to train others.
* Ability to think strategically and critically evaluate risks related to regulatory affairs.
* Understanding a Laboratory environment, techniques and principles.
* Some knowledge of sterilisation techniques and Microbiology.
* Knowledge of gas chromatography.
The above duties and responsibilities are not an exhaustive list, and you may be required to undertake any other reasonable duties compatible with your experience and competencies. This description may be varied from time to time to reflect changing business requirements.
Unisurge International Ltd is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity.
Job Types: Full-time, Permanent
Pay: From £75,000.00 per year
Additional pay:
* Bonus scheme
Benefits:
* Company pension
* Cycle to work scheme
* Employee discount
* Free parking
* On-site parking
* Profit sharing
* Referral programme
Schedule:
* 8 hour shift
* Day shift
* Monday to Friday
Work Location: In person
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