Our clients products are required to meet a range of stringent standards for quality and safety. Increasingly, their consumers also expect our clients products to come from socially and environmentally responsible sources. As brand owners, our clients work hard to comply with these standards to define and adhere to their own ethical values and company vision. However, it is also essential that they manage their suppliers to ensure that they also meet all these critical requirements. As a recognized leader of global supplier management and quality assurance services, our clients hire Infinite Sum to build and manage large supplier networks on their behalf all over the world.
We are currently seeking a Global Quality and Regulatory Manager (medical devices) who is looking for an exciting and challenging career with Infinite Sum – an employer that enables you to work in a flexible environment both in terms of geography and time.
This role will support Infinite Sum Global Sourcing and Procurement projects for our medical device clients located throughout the United States. We are now seeking a new Global Quality and Regulatory Manager (medical devices) to take full ownership of the technical functions and off-shore supplier relationshops within Quality and Regulatory, dealing with notified bodies and managing relationships with suppliers globally on behalf of our clients. The Global Quality and Regulatory Manager forms a central part of Infinite Sum senior management team within the medical industry and this role will play an important part of Infinite Sum growth in this sector going forward.
The key responsibilities for the Global Quality and Regulatory Manager will be:
- Regulatory framework analysis and strategy
- Identification, gap analysis & strategy for supplier compliance with relevant international standards
- Management of relationships with notified bodies and regulatory agencies e.g. BSI, FDA, Health Canada, TGA, MHRA.
- Product and supplier registrations for new and existing markets including: USA; Canada; & Europe
- Preparation, maintenance and management of technical files to support CE marking of medical devices and non-medical electronic products.
- Management of significant changes with notified bodies and regulatory agencies.
- Transition strategy, planning and implementation for New MDR
- Writing of new QMS Processes for regulatory compliance, and prepare, execute and write up of Audits. Management of CAPAs.
- Management of complaints and vigilance reporting.
- Minimum of 7 years of Quality Regulatory experience experience
- At least 3 years of external consulting experience or equivalent internal consulting project management experience
- Must be located within the Mid West of the United States, or be willing to relocate.
- Graduate Degree Preferred but not necessary if candidate can show 10+ years professional experience
The ideal candidate for the Global Quality and Regulatory Manager role will have the following background:
- Experience of quality and regulatory affairs in a heavily regulated environment - medical devices or consumer healthcare
- Expert knowledge of Medical Devices Directive, Canadian Medical Device Regulations, USA Food, Drugs & Cosmetics Act & 21 CFR; Australian Therapeutic Goods Regulations
- An understanding of the role of Regulatory affairs in a business context and the ability to exercise good judgement in determining reasonableness of actions.
- Demonstrable experience of regulatory submissions to major markets.
- Knowledge of global regulatory requirements for Class IIa/b devices.
- Leadership capabilities for working across varied cultures, expertise and backgrounds
- Ability to strategically interpret and respond to request from regulatory agencies.
- Outstanding interpersonal and communication skills for bridging understanding between scientific and business partners, for negotiating timelines, effective international collaboration and ensuring compliance of the organisation with regulatory requirements.
- Attention to detail and well developed organisational and analytical skills.
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Infinite Sum (i.e., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant status).
Candidates who are currently employed by a client of Infinite Sum or an affiliated Infinite Sum partner business may not be eligible for consideration.
What we can offer you
We will work with you to ensure you get an opportunity to work on project assignments that suit your personal and professional goals. Opportunity to work from home if wish, within a daily commute of a client location, or if you are adventurous we can post you to an international assignment working in multicultural and dynamic teams both internally and at our client sites. Career development opportunities are offered at all of our international offices.
What are the next steps?
If this sounds like the ideal role, career and company for you, click below to apply.
ABOUT INFINITE SUM
Infinite Sum is a global management consulting firm made up of experienced business executives and consultants that deliver immediate and long-term solutions and real profit to our clients. Since 1993, we have been retained as consultants and trusted partners to many clients ranging from fortune 500s to some with revenues of less than $100m.
Combining deep industry knowledge with specialised expertise in global sourcing, operations consulting and international market development and sales solutions we advise our clients on their most critical issues and opportunities relating to their global initiatives. We provide this advice and support across numerous industries and geographies, with particular emphasis on emerging markets.
Infinite Sum is an equal opportunities employer and welcomes applications from all sections of society and does not discriminate on grounds of race, religion or belief, ethnic or national origin, disability, age, citizenship, marital, domestic or civil partnership status, sexual orientation, or gender identity or any other basis as protected by applicable law.