Director, Regulatory Affairs

Overall regulatory lead for the Fertility Equipment business unit and UK-based regulatory team. UK Responsible Person and UK Importer of Record obligations. Support for senior leadership team regarding regulatory strategy and NPI project deliverables. This role is the Person Responsible for Regulatory Compliance (PRRC) for RI devices (Fertility equipment and consumables). This role will be responsible for collaborating with cross functional teams with internal and external customers, including Marketing, Product Engineering, R&D, Quality, other Coopersurgical RAQA teams and Coopersurgical subsidiaries, and external registration agent, distributors and regulatory bodies.

Responsibilities

• Ensure the global regulatory strategy for assigned project(s) is consistent with the business objectives and have been negotiated with relevant local and international health authorities as appropriate.
• Assist senior leadership in defining regulatory strategic plans, associated risks and possible mitigation, and effectively communicate to all applicable stakeholders.
• Monitor changes in the regulatory environment with potential strategic impact, working closely with the SPV RAQA.
• Responsible for line management and development of RA direct reports for Coopersurgical’s manufacturing site located in the United Kingdom.
• Identify areas in need of improvement and lead the development and implementation of process improvements and performance metrics tracking.
• Allocate and manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to meet the project deliverables & due dates.
• Responsible for hiring, firing, performance appraisals and pay reviews of direct reports.
• Lead for significant general projects for the function, including due diligence activities, MDR & IVDR submission schedule and compliance, new product introductions, product obsolescence, etc.
• Responsible for establishing and maintaining the compliance with quality systems requirements applicable to the regulatory affairs department like management review, training, etc.
• Active participant to both internal and external audits proceedings.
• Responsible for UK Responsible Person and UK Importer obligations for CooperSurgical’s products sold to the UK market.
• Required to work closely with cross functional Senior/Executive Leadership as well as Falmouth Management team members.

PRRC Responsibilities

• The PRRC is responsible for the company’s regulatory compliance by ensuring the relevant articles per Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostic Regulation (EU 2017/746) are fulfilled for CooperSurgical, Inc.
• The person responsible for regulatory compliance shall be responsible for ensuring that:
• The PRRC will check the conformity of devices in accordance with the quality management system (QMS) the company uses before the device is released.
• PRRC will ensure that technical documentation and the EU documentation of conformity are generated and up-to-date.
• The PRRC will make sure the company complies with post-market surveillance obligations listed in Article 10(10) of MDR and Article 10(9) of IVDR.
• Additionally, the PRRC will be responsible for ensuring that the company fulfills its reporting obligations, found in Articles 87-91 of MDR and Articles 82-86 of IVDR.
• Finally, the PRRC will ensure that the statement from Section 4.1 of Chapter II of Annex XV of the MDR is issued if the company is building an investigational device. For the IVDR, this statement is located in Section 4.1 of Annex XIV.

Qualifications

• Education: A minimum of bachelor's degree with Engineering / life science discipline (with an advanced degree preferred).
• Experience: A minimum 10-15 years Medical Device experience, of which at least 5 years is in Regulatory experience in the Fertility and/or In Vitro Diagnostics products.
• Qualifications, Knowledge, Skills and Abilities:
• Expert regulatory knowledge on various risk classes, but especially electrical devices and those containing software within the EU, US, Australia, Canada, and China territories.
• Experience with developing and implementing competitive regulatory strategies.
• Experience with line and matrix management.
• Demonstrated track record in securing product approvals and maintaining a complex portfolio.
• Experience dealing with broad range of stakeholders at all levels internal and external to the company and across geographies.
• Advanced leadership skills and demonstrated competence in employee management and development.
• Knowledge of and broad experience with regulatory procedures and legislation for product development, product registration, line extension and license maintenance- at the global level.
• Direct experience of leading regulatory authority meetings in different phases of product development.
• Direct experience and understanding of GMPs, GLPs and overall quality system requirements applicable to manufacturing of Medical Devices.
• Excellent written and verbal communication skills; able to communicate effectively and appropriately with internal and external stakeholders.
• Able to work independently as well as part of a team; demonstrated experience building a strong team environment.
• Able to excel in a high-pressure, fast-paced, and ever-changing environment; adapt to frequent changes, delays, or unexpected events while meeting objectives, budgets, and timelines.
• Strong interpersonal skills and maturity in working with all levels of the organization.
• Demonstrated ability to monitor own work to ensure quality, accuracy and thoroughness.
• Strong organizational, analytical and time-management skills.
• Able to self-motivate and work both independently and as part of a team.
• Ability to meet timelines and drive regulatory process to completion.
• Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
• Creates a learning environment, opens to suggestions for improvement.

Travel

• Travel to Falmouth Manufacturing site on an as needed basis.
• Travel to other CSI sites as necessary.
• Travel to locations where training is delivered or to conferences, UK and overseas.

Our Benefits

As an employee of CooperSurgical, you will receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits.