We are looking for a Senior Product Manager to own the development and operational delivery of a medical device software application that plays a key role in one of CLM's novel drug-digital combination products.

We'll be looking to you to align various parts of the organisation around a common vision, plan and set of focused incremental goals to get there. You'll work with UX, Technology, Drug, Clinical, Regulatory, Commercial and Business Development experts/teams and will own the road map for the medical device.

You'll also be responsible for key Quality Management activities, such as signing off requirements, managing the risk of the medical device application, and performing ongoing monitoring of the device once it is on the market.

What you'll be doing:

Leading new product development - the new Product Manager should own the vision for the medical device and be responsible for communicating this clearly to the whole company.

Value proposition - support the development of the value proposition with all key stakeholders, and confirm product/market fit through market research, user testing, or other product management techniques as needed.

Plan and develop the product road map, including any optionality or key decision points, then enable others to deliver to this by supporting the translation of roadmap elements to short-term deliverables.

Ensure the product roadmap is stable enough to support planning activities, but adaptable enough to deal with changes that may arise due to market change, competitor threats, or new regulations.

Fulfil regulatory requirements. The product development and post launch iterations will need to satisfy regulatory requirements of both device and drug components, and you'll need to ensure these needs are met, with direction from Regulatory colleagues.

Data related requirements, including cyber security. The Product Manager will ensure their product meets data governance requirements in terms of regulatory, product features (including AI) and good business practice.

Competitor analysis - work with the commercial team to understand and competitor risks or opportunities and ensure these are addressed in the product roadmap.

Product launch - work with marketing, operations and development teams to ensure the right pieces are in place to successfully launch and operate the product. Facilitate the go/no go decision for launch.

Lifecycle - identify and setup sources of product feedback, interpret and understand feedback received, and update the roadmap or other related product plans to make changes/improvements as needed.

What you'll bring:

Experience as a Senior Product Manager in a high-pace and high-growth environment, preferably in a Digital Health or Medical Device company (at least 3-5 years industry experience).

Strong project management experience with a proven track record of delivering world-class software as a medical device; experience in leading cross-functional project teams in an agile environment.

Verification & Validation - QA and regulatory oversight. The Product Manager should be well versed in what it takes to put the product on the market and work hand in hand with Quality Assurance.

Pragmatic attitude and deep business understanding of fast-moving start-ups in a regulated environment.

Ideally a combination of experiences in both a pure start-up as well as a more established company. This will enable the Product Manager to bring perspective that will set them up to be successful during the early days, whilst also understanding what structure is required in a more established company.

An understanding of regulated technology and life sciences products to facilitate smooth communication with both engineers and clinical teams.

Desirable but not mandatory:

Medical experience or experience operating in a highly regulated industry

Familiarity with regulatory standards such as IEC 62366.