EU Regulatory Expert for Medical Devices and In-Vitro Diagnostics

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

EU Regulatory Expert for Medical Devices and In-Vitro Diagnostics position is responsible for leading the Clinical Operations team within our global MedTech team at ProPharma.

In this role, you will be responsible for providing management and direction for all planning, logistics, and operational goals for the team.

Main Responsibilities:

• Hold kick-off meetings with the clients in connection to project start (when acting as Project Manager).

• Set up a regulatory and / or QMS strategy when needed.

• Use the project plan (if applicable) when acting as Project Manager.

• Ensure regular meetings with the clients are held as part of the overall project scope.

• Ensure project stays within project scope and manages CNF / CIS accordingly (when acting as Project Manager).

• Communicate with other service lines for cross service clients.

• Ensure regular meetings with the clients are held as part of the overall project scope.

• Hold business review and check-in meetings, as necessary (frequency based on revenue expectations).

• Ensure participation in client meeting training.

• Organize annual Group Structure review and planning with leadership.

• Target built in agreed working capacity to take on new projects working with an agreed target capacity.

• Monitor invoiceable performance metrics (80% target) weekly for consultants and Managing Consultants at (30%). Respond to leadership queries and investigates and discuss deviations as a normal working practice. 

• Ensure the company organogram is kept up to date by initiating a job change in the HRIS when group / structural changes occur. It is the duty of HR to update the diagram itself.

• Act as a backup to attend the monthly EU senior management committee meeting.

• Act as a backup to attend the monthly global committee meeting for senior management.

• Attend regular 1-1 meetings with leadership and discusses updates on group information and utilization metrics.

• Alert leadership when existing resource may be insufficient for existing or potential new projects.

• Obtain leadership buy in for recruitment cycle including level of recruitment needed and timelines on at least a quarterly basis or as often as needed.

• Monitor the Medical Device team turnover rate at 6 monthly intervals and alert the MedTech Global Head to any changes significantly above historical trending and looks for year on year reductions through a coordinated plan. Report available from HR.

• Attend regular meetings with Business Development ahead of recruitment activities to discuss project pipeline.

• Attend scheduled recruitment meetings with permanent and freelance recruitment.

• Responsible for workload allocation. When allocating workload projects and activities the following is considered: Business need & the client contract, available resource within the group, staff skill sets and technical competence to undertake activities and staff development needs.

• Keep up to date with latest regulatory guidelines and have the ability to assist members of staff on pathways forward where required.

• Communicate any sales opportunities to Business Development

• Follow the business operations process for acting as a Subject Matter Expert (SME), for new contract discussion teleconferences & email queries for expert input, where relevant.

• Understand client requirements and review contract proposals to ensure they are suitable for client’s needs.

• Up to date knowledge of the regulatory groups pricing.

• Have a good understanding and practical working knowledge of standard Master Service Agreements, Proposal and Work Order templates and Contracts & Timesheets Management System databases that ProPharma employs. 

• Work with Business Development and staff development plans to look at relevant conference attendance where required. 

• Input into regulatory marketing campaigns with the marketing department and ensure cohesive message with business development, where relevant.

• Develop a strong understanding of ProPharma services, staff levels and time estimations for all regulatory affairs activities the company offers.

• Build a strong awareness and working knowledge of ProPharma network of partners and affiliates to support clients and proposed projects. 

• Obtain a strong working knowledge of ProPharma vendor selection process and how to add persons and companies to ProPharma network.

• Input into contract tenders and vendor qualification activities on the company’s behalf in conjunction with business development.

• Review NDA / CDA / MSA / WO and provide SME approval for WO for business development within agreed timelines (where relevant).

• Attend regular business development meetings.

• Ensure the Medical Device Team are up to date with the company’s latest contract, timesheets, and invoicing training in conjunction with the quality lead (new starters within 4 weeks and annual refresh for all other staff).

• Ensure (via the Managing Consultants, where applicable) the group as a unit does not run over time on contracts or perform out of scope activities at a loss to the company. Where possible, any risks should be known in advance of running over contract.

• Work (with the Managing Consultants, where applicable) with finance and business development to give input and help resolve invoicing issues where they arise.

• Follow the process with set responsibilities from contract signature to staff timesheet set-up.

• Create / provide input, implementation, and maintenance of processes according to timelines and responsibilities listed in the Regulatory Operations group process planner.

Necessary Skills and Abilities:

• In depth knowledge about EU-MDR, IVDR, ISO13485, associated legislation and guidance documentation. Knowledge about legislation from other regions is preferred.

• Experience in leading Regulatory teams and Senior Regulatory Managers.

• Strong commercial awareness and aptitude.

• Strong knowledge of and insight in the developments within own disciplines.

• Strong knowledge of relevant national and international standards and guidelines in the pharmaceutical law and relevant guidelines.

• Strong knowledge of the products and services of the organization as well as the product and service portfolios of competitors and relevant markets.

• Strong project management skills.

• Knowledge and understanding of all social, political, financial, economic, and technical affairs that are strategically relevant to the organisation.

• The ability to ‘step back’ from situations and map out scenario’s and think through potential impact in advance.

• The ability to discuss client objectives, navigate the regulatory pathway, and propose strategic solutions (where feasible) to projects in verbal and written format.

• Strong interpersonal skills, communication, and negotiation skills.

• Excellent attention to detail and focus on quality.

• Strong verbal and written communication skills in.

• Ability to prioritize workload and meet deadlines both for self and for team.

• Capable of resolving conflict in a constructive manner.

• Ability to collaborate with others to meet company objectives.

• Ability to speak effectively in interpersonal situations and presentations before groups of employees and clients.

• Flexible and proactive toward changing needs.

Educational Requirements:

• Bachelor's degree in life sciences or a related field.

• Advanced degree (e.g., MS, PhD, PharmD) is preferred.

Experience Requirements:

• 10+ years’ medical device regulatory, QMS and management experience (consultancy preferred).

• Strong preference for a German speaker (preferred).

• In depth knowledge about EU-MDR (Regulation 2017 / 745), IVDR (Regulation 2017 / 746), ISO13485, associated legislation and guidance documentation. Knowledge about legislation from other regions is preferred.

• Proven track record of supporting successful regulatory submissions and approvals for investigational and / or marketed products as a Medical Device / IVD Subject Matter Expert.

• Experienced with combination products, Companion Diagnostics, and other medical device product variations.

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