Regulatory Affairs Engineer

Regulatory Affairs Engineer

Description -

The Regulatory Affairs Engineer works as part of the RA team to support the my clients organisation globally in the delivery of its products in a regulated environment. You will work closely with business areas including manufacturing and supply chain, research and development and engineering. You will liaison with regulatory authorities. This is a high impact role that works in a fast paced dynamic environment and makes a meaningful contribution to the business.

• To provide technical RA and Compliance support to the assigned departmental team.
• To proactively identify continual improvement opportunities and direct improvement activities within the assigned team, achieving improved efficiency and securing regulatory compliance in alignment with my clients priorities and the Q&RA business needs in conjunction with the RA Director.

• To proactively support the organisation in achieving & maintaining the necessary regulatory clearances needed for targeted market areas.
• To provide a center of competence and support for worldwide regulatory activities including those relating to the US Food and Drugs Administration-(FDA), Canadian Medical Device Regulations, Japan and China.

• To proactively support the organisation in achieving the necessary product standard compliance needed for targeted market areas.

• Maintaining a source of knowledge on worldwide product related standards applicable to the business;

• Providing the business with expertise on applicable standards and their interpretation
• Reviewing engineering change and its consequential effect on product compliance, including IEC, UL, CSA, JIST
• Interfacing with 3rd party certification bodies
• Collaborate with company Regulatory Intelligence.
• Reviewing and advising on issues arising from installed base products for impact on product compliance

Responsibilities -

• RA representation within projects
• Commits to Quality - Adheres to and improves processes and work
• Drives change - Identifies, plans, and implements changes
• Demonstrates integrity - Positive relationships and honest dependable results
• Provides creative solutions - Offers proposals and ideas to solve problems
• To perform regulatory review of business documentation e.g. Field change Orders, Marketing material, application training etc.
• Provide guidance on product regulation and translate into meaningful business requirements
• Gain market access for our regulated products including submissions
• Communicate with regional and business teams and prepare responses on all governing agency actions

• To provide Technical RA, Compliance support and facilitate resolutions to assigned area of responsibility.
• To support Manager in creating departmental strategies to achieve set departmental goals and objectives.
• To liaise with external Regulatory Bodies and internal regulatory functions within the company.
• To identify and provide advice and guidance on worldwide regulations throughout the organisation and to ensure that up to date knowledge is maintained and implemented within the business.
• To control the preparation and maintenance of submissions to regulatory authorities for all targeted market areas.
• To collaborate with compliance Engineers to provide Regulatory advice and guidance, particularly in the area of producing regulatory compliance plans
• To support the Customer Feedback Reporting (CFR) process, particularly in the areas of initial regulatory review and CFR summary closure form sign off.
• To perform regulatory review on business documentation e.g. Field Change orders and Marketing/Web publications.
• Commercial Catalogue and equipment Accompanying Documentation.
• To work with Commercial and Logistic functions to ensure products are promoted and shipped to markets where product safety & compliance, translations, export control, licencing requirements etc., have been achieved
• To provide guidance and assist collaborative ventures and other companies within my clients business areas.

Compliance

• To initiate activities to ensure worldwide compatibility in design product compliance.
• To lead the regulatory compliance planning and reporting process to ensure compliance representation at the earliest stages of Projects.
• To facilitate standards compliance verification activities and maintain standards compliance files.
• To monitor the production of applicable worldwide standards and their transition dates for company products.
• To provide an interface with Certification Bodies
• To assure third Party manufacturers compliance competencies
• To advise on installation issues relating to new product development and the installed base.
• To approve compliance evidence and status
• Provide training and development support to junior members of the RA team.

Relevant Knowledge, skills and competencies -

• To be successful in this role we would prefer solid experience in Regulatory Affairs. You have gained experienced at an industrial company working with manufacturing or product development, preferably in the MedTech or Pharma industry.
• We value experience from working with quality assurance, compliance issues and experience from working with internal and external audits.
• We also value your ability to apply your expertise to a variety of problems and being able to find smart solutions within the regulatory and quality area. Your English skills are excellent, both orally and written.
• You have a Master of Science degree (Mechanical, Electrical, Industrial Engineering, etc.) or equivalent engineering degree.
• We are looking for a regulatory affairs professional, preferably with experience in particular product submissions strategies and handling, or equivalent.

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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