Quality Manager

Description:

Appointed Management Representative

Lead, coordinate, author and review regulatory filing documents

Prepare US FDA submissions and CE Mark technical documentation files, including 510(k)

submissions, Device Master files, technical files and post market surveillance for product changes

and/or new products as required to ensure timely clearance or approvals

Collect documentation and coordinate with cross-functional teams to prepare regulatory submissions

to regulatory agencies

Create and maintain regulatory submission timelines and track deliverables to ensure company goals

are met

Develop and execute company’s regulatory strategy in the US, EU, Canada and other international

markets

Provide strategic input and regulatory advice to project teams and development programs including

new product development and changes to existing products

Keep abreast of current regulatory landscape for medical devices globally, e.g. FDA guidance

documents, EU MDR, EU guidance documents, etc.

Develop and communicate recommendations regarding new/emerging regulations to management

and project teams

Represent the company and work directly with regulatory authorities on regulatory issues and

submissions

Provide in-house training on quality/regulatory related issues

Support international RA and QA efforts and collaborate with other teams across the company as

needed

Experience Level:Expert LevelAbout Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.