Regulatory Affairs Manager

Salary: £150000 to £999999
Contact name: Selina Maini

Contact email: selina.maini@medella.life
Job ref: 526
Published: about 1 month ago

The company

My client is a leading MedTech company specialising in areas such as Orthopaedics and Neurotechnology. They have created a fun and collaborative environment and due to their success, they are growing at an exciting rate! They are seeking a Regulatory Affairs Manager to join them in nurturing and growing the business. This is a full time permanent remote position.


Summary

The Manager, Regulatory Affairs (RA) works with a high level of autonomy to bring medical devices to market and ensure ongoing compliance while managing a regulatory team.


Essential Duties and Responsibilities

  • Represent the company in interactions with external organizations including the FDA and other global health authorities, sponsors, and other organizations; serve as a primary Regulatory contact during all premarket activities and work with the company organizations to support the regulatory approval and commercialization efforts in global markets.
  • Develop/approve and implement global regulatory strategies that ensure procedures and policies meet applicable regulations.
  • Plan and manage key projects to ensure resources and support are provided as needed and report metrics to upper management.
  • Provide expert review of FDA submissions, design dossiers, technical files, post market submissions, and other regulatory documents. This includes establishing and maintaining necessary written procedures, such as for submission review and approval, and review of the significance of device modifications to regulatory bodies such as the FDA, MHRA, PMDA, etc.
  • Ensure new regulations or changes to existing regulations are communicated throughout the organization through company policies, procedures, and training.
  • Direct liaison activities with regulatory agencies, preparation, and submission of regulatory documents, as well as management of the regulatory archive.
  • Develop and interpret regulatory requirements from global markets, recommend to Regulatory Affairs and Quality Assurance (RAQA) Management specific activities and resources required to support and execute strategies to further the global growth of the business
  • Identify evolving regulatory trends including international trends that are relevant and ensure that appropriate action is initiated.
  • Serve as an internal resource to address and resolve any questions or issues of a regulatory nature; provide oversight to RA team to ensure that regulatory decisions are sound and in support of the strategic goals
  • Work with the RA Management Team to ensure that systems and process are integrated with the company Corporate RAQA.
  • Interface with key staff members in strategic planning, product development, operations, and customer service departments to meet scheduled submission dates.
  • Participate in Notified Body and Health Authority inspections.
  • Evaluate data generation carefully in line with scientific principles and company policies. Review and edit materials to meet regulatory requirements and company policy.
  • Participate in joint ventures with other companies to develop and address all necessary considerations involved with reprocessing single-use medical devices.
  • Oversee and/or approve the development of product labels and labeling, and ensure that processes and procedures for product labels and labeling are adequate to meet regulatory requirements.
  • Provide team with ongoing developmental opportunities, supporting team building activities, and promoting a healthy work/life balance.
  • Ensure that direct reports are achieving the business objectives and their professional development objectives.
  • Participate in activities of the Association of Medical Device Reprocessors (AMDR) in reviewing and responding to FDA proposals for regulation of medical device reprocessing.
  • Responsible for the review of collateral material process and works with legal and marketing to ensure collateral material that meets internal and external requirements.
  • Respond to Customer/Sales representative questions and issues.
  • Manage prioritization of team workload and address resource issues as they arise.


Qualifications (Education, Certifications and/or Experience)

  • Bachelor's degree in a scientific discipline.
  • Minimum 9 to13 years of experience in regulatory affairs in the medical device, biotechnology or contract research industry.
  • Minimum of 2 years management experience in medical device regulatory affairs, experience with GMP, QSR and ISO compliance.
  • Previous management overseeing professional/technical employees.
  • RAC preferred.
  • Experience with FDA, Health Canada, MDD/MDR and MHLW/PMDA regulations and compliance; preference for further experience with TGA, ANVISA and other global health authorities.
  • Regulatory experience in medical devices with Class I, II, and III in the US; class IIa, IIb and III in Europe, or Class II, III, IV products for other global markets highly preferred.
  • Significant 510(k), IDE, PMA, EU MDD 93/42/EEC Technical File/Design Dossier (original/revision/supplements) preparation, review, and submission experience highly preferred.
  • Thorough knowledge of FDA, QSR and ISO standards, regulations and requirements.
  • Ability to understand, interpret, and explain complex development details and regulations to non-experts.
  • Must be able to effectively interact with internal and external customers to obtain accurate information.
  • Must possess the ability to handle different projects with competing deadlines.
  • Demonstrated ability to develop direct reports, encourages a team dynamic, and promotes a healthy work/life balance.
  • Demonstrated ability to coordinate and prioritize workload in collaboration with cross-functional colleagues.

 

Connect

If you believe that you are the right person for this role, please apply now. Alternatively, if you believe you know somebody in your network who would be suited to this position please forward the details, we offer a competitive referral fee. We also have a presence on LinkedIn and Twitter, or you can sign to our mailing list on our website to be kept up to date with our roles.


Medella Life

As specialist recruiters in life sciences, our mission is to create a positive impact in the world. We place visionary people in thriving cultures where they can create a brighter future. Our impact and what that means to society is why we go the extra mile. We even baked it into our name, Medella, which means to heal. Pairing brilliant scientists with brilliant companies we find wildly exciting, and it drives everything