Sr Manager Compliance Bardi

Sr Manager Compliance
Bardi
Emilia Romagna, Bardi

To ensure Mlnlyckes integrity in the area of clinical and medical affairs by being well versed and ensuring compliance to clinical quality assurance To ensure clinical compliance through advising M&E department and the Molnlycke organisation on laws, regulations and guidelines pertaining to clinical evidence generation, data collection, and health care compliance Establish clear communication and alignment with relevant internal and external stakeholders in regards to clinical compliance KEY ACCOUNTABILITIES Ensuring all clinical data collected is in accordance with all applicable laws and regulations including, but not exhaustive, ISO 14155, ICH/GCP and GDPR Accountable for the content of M&E policies, SOPs, WIs, and Forms in the Quality Management System (QMS) and ensure alignment with other parts of the QMS Accountable in regards to compliance for planning and execution of clinical activities and review of M&E vendors, including conduct of audits when required Accountable for being up to date on rules, regulations, and guidelines to ensure a compliant way of working within M&E as well as provide in house expertise on laws regulations and guidelines pertaining to clinical evidence generation, data collection and health care compliance Accountable for defining training needs and keeping the department informed and trained on rules, regulations and guidelines Prepare, participate in, conduct, and follow up on audits To liaise with the CMO and CCO for development and maintenance of health care compliance policies and procedures To liaise with international bodies and external parties involved in legal, quality and regulatory affairs pertaining to clinical evidence generation, data collection and health care compliance in order to allow for timely anticipation onnew developments To ensure a compliant way of working within the M&E department with regards to data and data handling, e. g.

the EU General Data Protection Regulation (GDPR).

Close liaison with the Molnlycke DPO KEY DECISIONS Develop and implement M&E policies, SOPs, WIs and Forms in QMS Ensure clinical compliance with regards to all M&E activities, including also data handling Prepare, participate in, conduct, and follow up on audits Vendor assessment with regards to compliance, including conduct audits when applicable Training of M&E department to secure compliance with laws and regulations QUALIFICATIONS AND EXPERIENCE Academic background in Life Science (medical, clinical or scientific) A 7-10 years experience of Clinical Research in a Medical Device/Pharmaceutical/CRO setting giving a seniority level of experience, secure an in depth knowledge of all aspects of clinical research rules, regulations, guidelines and trends within clinical research and health care compliance A minimum of 5 years' experience of developing and maintaining procedures for adherence to rules, regulations, and guidelines, including the ability to interpret laws, regulations and guidelines to a practical way of working Experienced in providing training internally and externally on rules, regulations, guidelines, trends and way of working within clinical research In depth knowledge of ISO 14155, GCP, GDPR, MDCG and MDSAP Good networking skills High ethical standards Strong communicator with the ability to say no when required Thorough attention to details in combination with a holistic mindset Fluent in English (written and spoken) About Mlnlycke Mlnlycke is a world-leading medical solutions company.

We design and supply solutions to enhance performance at every point of care from the hospital to the home proven every day.

We specialise in:

Wound management:

including dressings with Safetac such as Mepitel and Mepilex Preventing pressure ulcers:

with Mepilex Border used prophylactically and devices to help turn and re-position patients Surgical solutions:

including Mlnlycke trays, HiBi antiseptics and Biogel surgical gloves Mlnlycke was founded in 1849.

Nowadays our solutions are available in around 100 countries; were the number one global provider of advanced wound care and single-use surgical products; and were Europes largest provider of customised trays.

Our headquarters are in Gothenburg, Sweden and we have about 7, 800 employees around the world.