Getinge · 4 days ago
Sr. Manager, Regulatory Affairs
Merrimack, NH
Full-time
Onsite
Senior Level, Lead/Staff
$165K/yr - $200K/yr
10+ years expGetinge is a company committed to making life-saving technology accessible for more people. The Sr. Manager, Regulatory Affairs will be responsible for developing and implementing global regulatory strategies for the Endovascular product area, managing submissions and ensuring compliance with regulatory requirements.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Develop and oversee the implementation of strategies for new product development and life cycle design and manufacturing improvements to obtain and maintain global product licenses. The Endovascular regulatory team is directly responsible for U.S. FDA submissions and EU Notified Body submissions
Pro-actively ensure strategies are adapted to changing regulatory requirements, provide robust input to project teams to drive predictability of regulatory timelines, and raise awareness of potential issues and risks early and to appropriate stakeholders, including providing regulatory solutions for the Endovascular product area
Ensures the quality of submissions generated. Provides expertise and consultation on proper preparation of submission documentation and files to relevant departments. Liaises with internal organizations to provide/solicit guidance and support for complex submissions
Main point of contact for regulatory authorities, managing all communication, including pre-submissions and meetings with regulatory bodies
Leverage a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products
Assures that a positive working relationship is developed and maintained between staff and internal/external customers
Leads or assists with internal and external health authority audits for Regulatory department
Oversees and/or owns CAPAs pertaining to Regulatory department
Develops and maintains high level relationships with key contacts in regulatory agencies and trains junior team members on effective Health Authority meeting techniques and preparation
Encourage and lead others to find ways to continuously improve, learn about new scientific, technological, and Regulatory developments, develop new capabilities and learn from past challenge and experience in order to proactively adapt to change and drive innovative thinking
Monitors compliance with company policies and regulatory procedures consistent with EU and FDA
This position interacts directly with both external and internal auditors as the Subject Matter expert to ensure that the company’s global change control process maintains compliance to internal and external regulations
Assists in special projects as needed
Qualification
Required
A Bachelor's degree in Engineering, Science or related field is required
A minimum of ten years medical device regulatory experience is required
Experience leading interactions and negotiating with global Health Authorities (i.e. U.S. FDA, EU Notified Bodies) is required, including leading and/or assisting with Health Authority audits
Expertise in developing and executing successful regulatory strategies for U.S. Class III PMA devices and EU Class III devices is required
Experience with navigating regulatory compliance challenges (i.e. consent decree, field actions) is required
Understands the requirements of FDA 21CFR Part 820, EU MDR, MDSAP, CMDR and ISO 13485 and strong experience with standards management
Must have FDA and Notified Body interaction experience
Must have in depth knowledge of regulatory requirements
Must have experience with global labeling requirements
Must have solid knowledge and experience in matters relating to organizational skills and personnel management
Must demonstrate effective written and verbal communication skills, including technical writing skills
Must have experience with and have strong knowledge of regulatory submissions including Pre-Market Approval applications (PMA) and 510(k) Notifications. Additional experience with IDE and De Novo submissions is a plus
Must have demonstrated ability to mentor and develop a high performing staff
Team player who can communicate and collaborate proactively with all staff members to achieve corporate and project goals
Must be detail oriented and possess excellent organizational skills with a demonstrated ability to manage multiple projects with strict deadlines
Computer skills must include comprehensive knowledge of all current and common computer tools (e.g. MS-Excel, MS-PowerPoint, MS-Word) as well as some specialized applications
Preferred
A Master of Science in Engineering, Science or related field or MBA is preferred
RAC designation is preferred
People Leadership experience including management direct reports and developing team members is preferred
Company
Getinge
Getinge identifies customer issues and promotes clinical and economic benefits and follow and support the customer decision process.
10001+ employees
H1B Sponsorship
Getinge has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (3)
2023 (2)
2022 (2)
2021 (2)
2020 (5)
Funding
Current Stage
Public CompanyTotal Funding
$539.31M2017-10-19Post Ipo Equity· $539.31M
2002-06-28IPO
Leadership Team
C
Christoffer Å.
Chief Information Security Officer
Joanna Engelke
EVP Quality Compliance, Regulatory, Medical
Recent News
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2025-12-19
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