Regulatory Affairs Manager- Leading Manufacturer- Canton, Ma

Job Description

• Responsible to implement policies, procedures, practices and strategies for Regulatory Affairs.
• The successful manager will be a strategic partner for our R&D and Marketing teams, as well as effectively collaborate with International RA, Clinical, Quality, Manufacturing Operations and other required functions to execute regulatory strategies from product inception, launch and throughout the product life cycle.

The successful manager will be an active member of the Regulatory Affairs leadership team and manages department activities with responsibility for results in terms of costs, timing, methods and employees.

The manager is expected to accomplish results through hands on and delegation of responsibility to individual contributors.

This role provides leadership, coaching and career development for team members and positively contributes to the development and maintenance of a collaborative and successful culture.

• A Day in the Life Responsibilities may include the following and other duties may be assigned. Provides direction, leadership and coaching to staff to meet schedules and resolve technical or operational problems.
• Develops and administers budgets, schedules, and performance standards. Becomes actively involved in daily operations to meet schedules or to resolve complex problems;

responsible for personnel resource planning, forecasting and deployment. Develop global regulatory strategies for Access / Instrumentation to meet business objectives and collaborate across a matrixed organization to ensure global success of products.

Participate in strategic Product Development meetings, providing regulatory strategies, timelines, and direction. Reviews and approves technical documentation.

Organize and prepare high quality pre and post market submissions meeting US and EU MDR requirements which allow our local International RA team and Regional Business Units to obtain and maintain global product regulatory documentation, approvals and product renewals.

Participate in Business Development due diligence teams and provide assessment of target to inform business decisions Negotiate with regulatory authorities to resolve questions / issues that arise during the product lifecycle.

Drive product change assessments and collaborate with International RA team to define regulatory impact of product changes in global markets.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law.

MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

• We are looking for someone with a background in IVD regulatory compliance submissions experience supporting class one and class two medical devices.
• Experience with technical trials in the EU.
• Have strong organizational, written, and verbal communication skills.
• Have experience with pre and post market surveillance.

What's on Offer

• Flexible working environment. WFH Monday and Friday.
• This is a highly visible role. Reports to VP of Quality.
• Well known long standing company with great benefits.
25 days ago