Getinge
Overview
Sr. Manager, Regulatory Affairs — Getinge’s Endovascular product area within the Acute Care Therapy business. Location: Merrimack, NH, US. Company: Atrium Medical Corporation. Remote Work: 1-2 days at home (site based). Salary Range: 165,000-200,000 + 25% STIP. Job Responsibilities and Essential Duties
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. Proactively 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 with appropriate stakeholders, including providing regulatory solutions for the Endovascular product area. Ensure the quality of submissions generated. Provide expertise and consultation on proper preparation of submission documentation and files to relevant departments. Liaise with internal organizations to provide/solicit guidance and support for complex submissions. Serve as main point of contact for regulatory authorities, managing all communication, including pre-submissions and meetings with regulatory bodies. Leverage technical understanding of products to provide strategic guidance and support for product development and life-cycle management. Maintain positive working relationships with staff and external customers; lead internal and external health authority audits for Regulatory department; oversee CAPAs pertaining to Regulatory. Develop and mentor junior team members; train on effective Health Authority meeting techniques and preparation. Encourage continuous improvement and adoption of new scientific, regulatory, and technological developments to drive innovative thinking. Monitor compliance with company policies and regulatory procedures consistent with EU and FDA requirements; interact with auditors as the Subject Matter Expert to ensure change control and regulatory processes remain compliant. Contribute to special projects as needed. Required Knowledge, Skills and Abilities
FDA and Notified Body interaction experience; in-depth knowledge of regulatory requirements; global labeling knowledge. Strong organizational and personnel management skills; excellent written and verbal communication, including technical writing. Experience with regulatory submissions including Pre-Market Approval (PMA) and 510(k); familiarity with IDE and De Novo submissions is a plus. Proven ability to mentor and develop a high-performing staff; team player with proactive collaboration across functions; able to manage multiple projects with strict deadlines. Proficiency with MS Office and regulatory software/tools; strong technical/computer skills. Supervision/Management
Responsible for the development and management of personnel; indirect management of supporting staff as required to ensure timely project execution; manages at least two direct reports; accountable for hiring, development, and disciplinary actions within the Endovascular Regulatory team. Internal and External Contacts / Relationships
Quality, Customer Service, Operations, Commercial Operations departments Worldwide GETINGE and/or Distributor Regulatory Colleagues; Worldwide Health Departments Environmental/Safety/Physical Work Conditions
Adheres to environmental and safety practices; may require extended hours during peak business cycles; use of computer and telephone equipment. Qualifications and Education
Bachelor’s degree in Engineering, Science, or related field required. Master’s degree or MBA preferred. Minimum of ten years of medical device regulatory experience; RAC designation preferred. Experience leading interactions and negotiations with global Health Authorities (e.g., U.S. FDA, EU Notified Bodies); experience with audits. Expertise in regulatory strategies for U.S. Class III PMA devices and EU Class III devices; knowledge of FDA 21 CFR Part 820, EU MDR, MDSAP, CMDR, and ISO 13485. Education, Experience and Other
About us With a belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions to improve clinical results and optimize workflows. Getinge employs over 12,000 people worldwide and sells in more than 135 countries. Getinge is an equal opportunity employer. Qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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Sr. Manager, Regulatory Affairs — Getinge’s Endovascular product area within the Acute Care Therapy business. Location: Merrimack, NH, US. Company: Atrium Medical Corporation. Remote Work: 1-2 days at home (site based). Salary Range: 165,000-200,000 + 25% STIP. Job Responsibilities and Essential Duties
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. Proactively 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 with appropriate stakeholders, including providing regulatory solutions for the Endovascular product area. Ensure the quality of submissions generated. Provide expertise and consultation on proper preparation of submission documentation and files to relevant departments. Liaise with internal organizations to provide/solicit guidance and support for complex submissions. Serve as main point of contact for regulatory authorities, managing all communication, including pre-submissions and meetings with regulatory bodies. Leverage technical understanding of products to provide strategic guidance and support for product development and life-cycle management. Maintain positive working relationships with staff and external customers; lead internal and external health authority audits for Regulatory department; oversee CAPAs pertaining to Regulatory. Develop and mentor junior team members; train on effective Health Authority meeting techniques and preparation. Encourage continuous improvement and adoption of new scientific, regulatory, and technological developments to drive innovative thinking. Monitor compliance with company policies and regulatory procedures consistent with EU and FDA requirements; interact with auditors as the Subject Matter Expert to ensure change control and regulatory processes remain compliant. Contribute to special projects as needed. Required Knowledge, Skills and Abilities
FDA and Notified Body interaction experience; in-depth knowledge of regulatory requirements; global labeling knowledge. Strong organizational and personnel management skills; excellent written and verbal communication, including technical writing. Experience with regulatory submissions including Pre-Market Approval (PMA) and 510(k); familiarity with IDE and De Novo submissions is a plus. Proven ability to mentor and develop a high-performing staff; team player with proactive collaboration across functions; able to manage multiple projects with strict deadlines. Proficiency with MS Office and regulatory software/tools; strong technical/computer skills. Supervision/Management
Responsible for the development and management of personnel; indirect management of supporting staff as required to ensure timely project execution; manages at least two direct reports; accountable for hiring, development, and disciplinary actions within the Endovascular Regulatory team. Internal and External Contacts / Relationships
Quality, Customer Service, Operations, Commercial Operations departments Worldwide GETINGE and/or Distributor Regulatory Colleagues; Worldwide Health Departments Environmental/Safety/Physical Work Conditions
Adheres to environmental and safety practices; may require extended hours during peak business cycles; use of computer and telephone equipment. Qualifications and Education
Bachelor’s degree in Engineering, Science, or related field required. Master’s degree or MBA preferred. Minimum of ten years of medical device regulatory experience; RAC designation preferred. Experience leading interactions and negotiations with global Health Authorities (e.g., U.S. FDA, EU Notified Bodies); experience with audits. Expertise in regulatory strategies for U.S. Class III PMA devices and EU Class III devices; knowledge of FDA 21 CFR Part 820, EU MDR, MDSAP, CMDR, and ISO 13485. Education, Experience and Other
About us With a belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions to improve clinical results and optimize workflows. Getinge employs over 12,000 people worldwide and sells in more than 135 countries. Getinge is an equal opportunity employer. Qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
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