Job Description
We are seeking a Regulatory Manager for our client, a Medical Device organisation. Reporting to the General Manager, you will liaise with external Regulatory bodies, lead and manage a small but growing site-based team. You will be responsible for implementing & enforcing regulatory best practices. You will be expected to be a role model in exhibiting quality behaviours and continuously fostering the development and potential of others. RESPONSIBILITIES Implementation and maintenance of clauses and systems in compliance to ENISO13485:2016 including the applicable elements regional requirements, (21CFR820, HSA, MDD, MDR, MDSAP etc.) Manage the development and implementation of regulatory strategies to gain product approvals. Inform management about regulatory status of products and significant regulatory issues. Prepare and conduct all internal/external audits/inspections by any regulatory authority and clients. Oversee preparation and filling of all regulatory documents with relevant regulatory bodies. Lead regulatory changes that may impact compliance status or represent significant business risk. Act as management representative for regulatory authorities providing counsel, training and interpretation of regulatory standards and compliance to all personnel. Develop and maintain external relationships with key opinion leaders and regulatory officials Manage training and development activities. Be available to travel nationally and internationally to conduct audits and provide support for suppliers. REQUIREMENTS Degree in a science related area; Chemistry / Microbiology / Quality Management / Engineering / Technical discipline or demonstrated equivalent experience. Lead auditor certified. Risk management training to 1S014971:2012. In-depth understanding of the transition from MDD to MDR. Knowledge of global regulatory guidelines and best practice. Minimum of 5 years progressive experience in Regulatory Affairs. Technical knowledge and experience with European and US regulations. Ability to integrate scientific & regulatory considerations in developing & implementing regulatory strategies. QUALIFICATIONS AND SKILLS Experience of working within a regulated industry with knowledge of MDD (Medical Device Directive), ENISO13485 (Quality Management Systems), FDA, and Risk Management (ENISO14971) Experience in a leadership role with people management responsibility Ability to work with cross-functional teams: regulatory affairs, engineering, operations and warehousing. Ability to multi-task with an awareness of impact on production and plant performance. Organised, resourceful with excellent attention to detail and ability to get the job done Clear written and verbal communication skills. Determination and self-motivation. Ability to identify and focus on methodical problem resolution. Ownership for your professional development and implementation of new approaches. Excellent record of attendance and time keeping / adherence to company policy. Core Competencies reflect the culture of the company as follows: Customer Focus, Drive for results, Adaptability, Creativity, Problem Solving, Intercompany relationships. Does it sound like you? Please feel free to get in touch with our friendly team!