* Work with pioneering medical devices in the mental health field * Benefit from an experienced team, boasting longevity and achievable progression
SRG partner with a leading supplier of alternative mental health therapy. Their devices are unique - offering a non-invasive treatment that is proven to combat depression amongst other common mental health illnesses. They have a global reach with their products, with further growth plans in place.
As Regulatory Affairs Manager, you will provide leadership of the Regulatory function, ensuring the Company and its products, complies with all relevant requirements for all products in each territory into which it operates. Reporting to the Chief QARA director, you will be encouraged to provide a strategic focus to the growth of the division.
RESPONSIBILITIES* Provide proactive leadership to the regulatory function.* Fulfil the role as person responsible for regulatory compliance, as required by Article 15 of the European MDR (2017/745). The duties include:o ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released o ensuring that the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; o ensuring that the post-market surveillance obligations are complied with in accordance with Article 10(10); o ensuring that the reporting obligations referred to in Articles 87 to 91 are fulfilled; o ensuring that in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued* To execute the regulatory strategy, including but not limited to NPD, NMI, regulatory landscape changes.* Representing the Company in regulatory matters to influence outcomes and establish strong and valuable partnerships including communicating with regulatory and governmental agencies* Plan, direct and control all regulatory activities supporting the introduction of new products, modification or withdrawal of existing products. * Overseeing the process of preparing product submissions to domestic and international regulatory bodies and leading the process from inception to approval.* Define, implement and manage regulatory initiatives.* Maintain awareness of current and new regulatory requirements for all territories
EXPERIENCE/SKILLS* Considerable experience in senior regulatory roles in medical device industry or other highly regulated industries.* Formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline
* Advanced knowledge of MDD/EU MDR, FDA regulations, Health Canada regulations and all relevant harmonised / recognised standards.* Experience of leading problem-solving activities.* Experience of leading and improving small multi-skilled teams.
For more information, or to discuss your career in the Quality Assurance/Regulatory Affairs arena, please contact Holly Evans on firstname.lastname@example.org
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