On behalf of our client, we are looking for a full-time experienced Regulatory Affairs Specialist.
The daily duties and responsibilities include:
• Responsible for the implementation and maintenance of classes and systems in compliance to EN ISO 13485:2016 including the applicable elements regional requirements, (21 CFR, HSA, MDD, MDR, MDSAP etc.)
• Maintenance and compliance of EN ISO 13485:2016 and other regulatory standards when appropriate.
• Communicate regulatory issues to the wider company to assure full understanding and compliance.
• Act as the Person Responsible for Regulatory Compliance (PRRC), in lie with Article 15 of the EU MDR 2017/745.
• Provide management to the organisation in the development and implementation of regulatory strategies to gain product approvals.
• Responsible for keeping management informed about regulatory status of products and significant regulatory issues.
• Act as management representative for regulatory authorities providing counsel, training and interpretation of regulatory standards and compliance to all personnel within the organization.
• Must participate in all inspections/audits by any regulatory authority and customer.
• Oversee preparation and filling of all regulatory documents with relevant regulatory bodies.
• Develop and maintain external relationships with key opinion leaders and regulatory officials.
• Direct the development of systems, practices and processes to ensure efficient/effective ongoing review of product design and/or manufacturing and post market surveillance.
• Provide leadership and direction for significant regulatory changes that may impact compliance status or represent significant business risk.
• Participate in the Risk Management program.
• Conduct regulatory training, to build understanding of requirements in all levels of the organization.
• Execute internal audit process and third party audits, notified body and regional authority.
• Execution of assigned projects within cost and schedule requirements including the company initiatives lean, safety and cost reduction.
• Be available to travel both nationally and internationally as required conducting audits and providing support to suppliers and other companies association the group.
• Carry out additional duties that may be assigned to you.
Essential Requirements
• A Degree in a science related area, Chemistry/Microbiology/Quality Management/Engineering or other relevant degree.
• Knowledge of global regulatory guide lines and best practice.
• Minimum of 1 year experience in medical device Regulatory Affairs and
• Technical knowledge and experience with European and US regulations.
• Track record of success and a broad understanding of contemporary quality practices for medical device and combination product platforms.
• Relevant experience applying Quality Risk management for device product development and manufacturing.
• Ability to integrate scientific and regulatory considerations in developing and implementing regulatory strategies.
• Proficient in pertinent software, such as Microsoft office suite.
• Excellent written and oral communications.
Non-Essential Requirements
• Experience of working within a regulated industry with knowledge of MDR (Medical Device Regulation), EN ISO 13485 (Quality Management Systems), FDA, and Risk Management (EN ISO 14971)
• Experience in a leadership role with people management responsibility.
• Ability to work with cross-functional teams, including quality, engineering, operations and warehousing.
• Ability to multi-task and to work in an environment with an awareness of impact on production and the plant performance.
• Organised and resourceful with excellent attention to detail and ability to get the job done.
• Clear written and verbal communication skills.
• Determination and self-motivation.
• The ability to identify and focus on methodical problem resolution.
• Ownership for your own professional development and implementation of new approaches to doing things. Emphasis on simplicity of implementation.
• Ability to demonstrate commitment.
• Excellent record of attendance and time keeping/adherence to company policy.
Salary: Salary being offered is commensurate with qualifications and experience and is between $95,000 - $110,000 per annum
The daily duties and responsibilities include:
• Responsible for the implementation and maintenance of classes and systems in compliance to EN ISO 13485:2016 including the applicable elements regional requirements, (21 CFR, HSA, MDD, MDR, MDSAP etc.)
• Maintenance and compliance of EN ISO 13485:2016 and other regulatory standards when appropriate.
• Communicate regulatory issues to the wider company to assure full understanding and compliance.
• Act as the Person Responsible for Regulatory Compliance (PRRC), in lie with Article 15 of the EU MDR 2017/745.
• Provide management to the organisation in the development and implementation of regulatory strategies to gain product approvals.
• Responsible for keeping management informed about regulatory status of products and significant regulatory issues.
• Act as management representative for regulatory authorities providing counsel, training and interpretation of regulatory standards and compliance to all personnel within the organization.
• Must participate in all inspections/audits by any regulatory authority and customer.
• Oversee preparation and filling of all regulatory documents with relevant regulatory bodies.
• Develop and maintain external relationships with key opinion leaders and regulatory officials.
• Direct the development of systems, practices and processes to ensure efficient/effective ongoing review of product design and/or manufacturing and post market surveillance.
• Provide leadership and direction for significant regulatory changes that may impact compliance status or represent significant business risk.
• Participate in the Risk Management program.
• Conduct regulatory training, to build understanding of requirements in all levels of the organization.
• Execute internal audit process and third party audits, notified body and regional authority.
• Execution of assigned projects within cost and schedule requirements including the company initiatives lean, safety and cost reduction.
• Be available to travel both nationally and internationally as required conducting audits and providing support to suppliers and other companies association the group.
• Carry out additional duties that may be assigned to you.
Essential Requirements
• A Degree in a science related area, Chemistry/Microbiology/Quality Management/Engineering or other relevant degree.
• Knowledge of global regulatory guide lines and best practice.
• Minimum of 1 year experience in medical device Regulatory Affairs and
• Technical knowledge and experience with European and US regulations.
• Track record of success and a broad understanding of contemporary quality practices for medical device and combination product platforms.
• Relevant experience applying Quality Risk management for device product development and manufacturing.
• Ability to integrate scientific and regulatory considerations in developing and implementing regulatory strategies.
• Proficient in pertinent software, such as Microsoft office suite.
• Excellent written and oral communications.
Non-Essential Requirements
• Experience of working within a regulated industry with knowledge of MDR (Medical Device Regulation), EN ISO 13485 (Quality Management Systems), FDA, and Risk Management (EN ISO 14971)
• Experience in a leadership role with people management responsibility.
• Ability to work with cross-functional teams, including quality, engineering, operations and warehousing.
• Ability to multi-task and to work in an environment with an awareness of impact on production and the plant performance.
• Organised and resourceful with excellent attention to detail and ability to get the job done.
• Clear written and verbal communication skills.
• Determination and self-motivation.
• The ability to identify and focus on methodical problem resolution.
• Ownership for your own professional development and implementation of new approaches to doing things. Emphasis on simplicity of implementation.
• Ability to demonstrate commitment.
• Excellent record of attendance and time keeping/adherence to company policy.
Salary: Salary being offered is commensurate with qualifications and experience and is between $95,000 - $110,000 per annum
