Regulatory Affairs Senior Specialist

At CooperSurgical we are currently looking to recruit a Senior Regulatory Affairs Specialist . You will be part of the global regulatory team with 20 international colleagues. The position is hybrid position based out of Denmark office. The Sr. RA specialist will be reporting to the RA manager working out of UK.

Position

In the role of Sr. RA specialist, you will be responsible for regulatory activities such as registration documentation and product applications and renewals to local authorities primarily focus on FDA 510(K) and UK/EU MDR. You will identify and maintain documentation including updates and review of the technical files for the IVF devices product portfolio and support the MDR filling (class I,IIa). You will maintain the regulatory QP/QI´s in the quality management system in corporation with your fellow peers in regulatory affairs.

As a person you thrive in a dynamic and sometimes hectic environment and by using your planning and prioritizing skills, you meet deadlines and proactively follow-up on stakeholders. You will work closely together with teammates, interacting with different internal and external stakeholders. Therefore, it's vital that you possess good communication skills, and are committed to getting things done both individually and together with the RA team.

CooperSurgical is a leading fertility and women’s healthcare company dedicated to putting time on the side of women, babies, and families at the healthcare moments that matter most in life. As a division of CooperCompanies, we're driven by a unified purpose to enable patients to experience life's beautiful moments. Guided by our shared values – dedicated, innovative, friendly, partners, and do the right thing – our offerings support patients throughout their lifetimes, from contraception to fertility and birth solutions, to women’s and family care, and beyond. We currently offer over 600 clinically relevant medical devices to healthcare providers, including testing and treatment options, as well as an innovative suite of assisted reproductive technology and genomic testing solutions. Learn more at www.coopersurgical.com.

Travel:* Travel to Falmouth Manufacturing site on he request of Manager

• Travel to other CSI sites as necessary
• Travel to locations where training is delivered or to conferences, UK and overseas
• Less than 10% travel is required

*Qualifications**Knowledge, Skills and Abilities: In depth knowledge of medical device registration requirements for UK and EU market

• Demonstratable regulatory experience of electrical medical devices and software
• Ability to read and interpret medical device regulations and requirements
• Strong project management skills
• Effective communication and negotiations skills especially with Notified and Approved Bodies and other regulatory authorities or agents
• Good IT and administrative skills

Work Environment:* DK - Hybrid

Experience:* +5 years of experience in the medical device industry within RA or equivalent

Responsible for

• EU certification of medical devices and self-certification of non-medical device (General laboratory equipment)
• regulatory assessment of changes to devices, process, supply chain and regulations, and resultant notification and re-registration activities
• proactively monitoring changes in EU and UK medical device regulations, and share or provide training to global CSI Regulatory Affairs team, commercial, distribution and service teams

Essential Functions & Accountabilities:* Lead regulatory affairs projects and support strategy for CooperSurgical fertility equipment in EU (MDR), FDA 510(k)and RoW countries

• Manage the creation and maintenance of Technical Documentation Files for new, existing and acquired products
• Ensure effective project management for product certification, registration and re-registration in collaboration with notified bodies, local regulatory authorities, registration partners, certificated labs and global CSI Regulatory Affairs team
• Leads regulatory impact assessments and identify regulatory plan necessary for maintaining market access
• Proactively monitor changes in regulations and share or provide training to CSI Regulatory Affairs teams, commercial, distribution and service teams
• Regulatory representative and advisor for new product development
• Develop business relationship with key stakeholders and arrange necessary consultancy with local experts
• Provide regulatory support during surveillance audits as necessary to maintain international licenses, registrations and certification
• Work closely with the other CSI Regulatory Affairs team, to ensure alignment of activities and sharing of global best practices.
• Join Regulatory Affairs meetings as deemed appropriate
• To achieve measurable results in all certifications and ongoing submissions to provide visibility to all internal partners
• Maintain market clearance and approval documentation, and databases
• Participate in training and attend conferences, and meetings specific to role
• Lead Regulatory support for closure of Non-conformances raised at internal or external audits
• Provide Regulatory support with Vigilance reporting and recall (incl. FSCA) activities
• Develop business relationships with key stakeholders and arrange necessary consultancy with experts such as Notaries