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Position Overview
The Lead Regulatory Affairs Manager, International will support or lead the creation and submission of product Technical Files/Standard Technical Documentation and other submission related documents for market authorizations in targeted markets and countries. The Lead Regulatory Affairs Manager, International supports or leads the creation and execution of regulatory strategy for assigned projects, including new product development, product changes, and manufacturing improvement initiatives. This role assists in creating, developing, and implementing global regulatory affairs procedures and educating others on global regulatory expectations and requirements.
Essential Duties
Include but are not limited to the following:
- Participate, lead or support the preparation and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution approvals and/or clearances.
- Support or lead as needed regulatory strategy development, document appropriate regulatory strategy for proposed new products and markets and initiate necessary activities by working with project teams and regulatory team members as needed.
- Control and maintain regulatory records.
- Represent Regulatory Affairs on project teams by attending team meetings and providing the required plans, procedures and regulatory decisions.
- Manage distributors and RA consultants to ensure global registrations are completed on time and maintained.
- Review and approve documents and product changes for regulatory compliance, determining if a new premarket application is required.
- Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry.
- Review and approve product labeling and marketing material.
- Provide Regulatory reviews and approvals of advertising, promotional and external product training materials in compliance with applicable regulatory and trade requirements and Exact Sciences Medical, Legal and Regulatory (MLR) review process.
- Demonstrate continuous pursuit of global regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including IVDR, UK CA, FDA and Health Canada regulations and policies applying to In Vitro Diagnostic medical devices including, PMAs, 510(k)s, labeling and promotional materials, global registration, and technical writing.
- Experience with regulators in the Middles East and/or Latin America will be a plus.
- Strong technical writing skills.
- Effective communicator: ability to convey messages in a logical and concise manner. Consistently reinforce regulatory expectations and requirements.
- Exceptional attention to detail.
- Strong organizational skills.
- Independent self-starter; manage time effectively and complete tasks on-time with minimal supervision.
- Flexible and able to self-manage multiple priorities.
- Ability to work effectively in multinational/multicultural environments.
- Adapt readily to changes in workload, staffing, and scheduling.
- Comply with management direction. Seek assistance from supervisor in identifying and reporting problems or concerns relating to job functions.
- Conduct self in a professional manner with coworkers, management, customers, and others.
- Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
- Support and comply with the company’s Quality Management System policies and procedures.
- Regular and reliable attendance.
- Ability to work designated schedule.
- Ability to work nights and/or weekends as needed.
- Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 75% of a typical working day.
- Ability to work on a computer and phone simultaneously.
- Ability to use a telephone through a headset.
- Ability to travel 30% of working time away from work location, may include overnight/weekend travel.
Minimum Qualifications
- Bachelor’s degree in Physical or Life Sciences; or a High School Diploma/ General Education Degree (GED) and at least 5 years of relevant career experience in lieu of Bachelor’s degree.
- 7+ years relevant experience in a regulated pharmaceutical or medical device environment.
- Basic computer skills to include Internet navigation, Email usage, and word processing.
- Proficient in Microsoft Office.
- Authorization to work in the European Union.
- Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
Preferred Qualifications
- Bachelor’s degree in Science or Health related discipline.
- Professional working knowledge with reviewing and approving product advertising and creating product labeling.
- Professional working knowledge with adverse event reporting and is familiar with post-market surveillance and vigilance requirements.
Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.
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