Remote Regulatory Affairs Specialist with IVD experience

We are looking for a Regulatory Affairs Specialist who will work with a team to develop and execute international strategies and submissions for regulatory approval of medical device products. We are especially interested in candidates with US IVD experience. This person will join our Mhetra MSP (Managed Service Provider) division. This role is full-time and consists in supporting our remote locations (Switzerland and USA) of our startup life science service company, whose main clients are in the US, EU, and Asia. (Compensation: 50K - 70K $ base salary, Bonus ~55,000 – 100,000 $ per year)

The Company

Mhetra is a small MSP and PEO (Managed Service Provider and Professional Employer Organization) agency which supports pharmaceutical, medical device, and life science companies in gaining and maintaining market access globally. We assure the success of our customers and partners:

• by managing their functional business processes (outsourced to Mhetra), and/or
• by assigning qualified personnel to manage their internal processes.

Our dynamic team does not only secure high level of expertise and process efficiency for our clients, but our creative service solutions result in attractive cost and time savings. Our mission is to promote global public health by contributing and supporting the impactful objectives of our clients and partners. We are currently located in the USA and in Switzerland.

THE ROLE

As the Regulatory Affairs Specialist you’ll oversee the operation activities being handled by our virtual office members (currently 15-30 freelancers), including determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the appropriate regulatory authorities worldwide.

You will work hand in hand with one of the co-founders of Mhetra, an American who has been living in Switzerland for the past couple of years.

Key Responsibilities Include

• Coordinating, compiling and submitting U.S, and/ or International regulatory submissions, including filing and/or creation of IDEs, Premarket Notifications, PMA Supplements, Change Notifications, Technical Documents, Technical Files, Design Dossiers, and other country-specific product registrations.
• Assisting clients with regard to obtaining marketing authorization for medical devices, drugs, drug-device combination products, IVDs, and dietary supplements (regulatory strategies, listing, 510(k), PMA, IDE, NDA, BLA, etc.).
• Managing the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products.
• Performing mock-inspections regarding fulfillment of regulatory requirements.
• Assisting clients in preparation for inspections / pre-approval inspections.
• Establishing quality management systems according to ISO 13485, Council Directive 93/42/EEC, SOR/98-282 (Canadian Medical Device Regulation), 21 CFR Part 820, 21 CFR Part 210/211, and 21 CFR Part 4.
• Implementing compliant design control processes (including risk management and change management).
• Working in new product development projects, managing strategies, submissions, license renewals and annual registrations.
• Maintaining and updating information about global regulatory requirements.
• Representing the company towards notified bodies and authorities at the global level, responding to requests/inquiries about regulations and product compliance.
• Supporting post market surveillance activity including assembling necessary evidence and preparing summary reports as appropriate.
• Completing timely regulatory safety evaluations on customer complaints and manufacturing non-conformance activities for regulated products.
• Providing guidance regarding regulatory and performance test requirements for product claims and the design verification and validation of regulated and non-regulated products.
• Reviewing device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
• Anticipating regulatory obstacles and emerging issues throughout the product lifecycle and developing solutions with other members of regulatory and related teams.

THE CANDIDATE

You’ll be an English speaker who has a bright and proactive personality, in keeping with the ethos and spirit of this friendly and dynamic agency.

Key Requirements

• Minimum 5 years of relevant experience in a regulatory affairs position.
• Bachelor level degree required preferably in engineering, chemistry, physics, biology or related life science.
• Regulatory Affairs Certification (RAC) is preferred.
• Fluent in both written and spoken English.
• Experienced working directly with FDA, notified bodies and/or international health authorities.
• Experienced in the regulatory framework in Medical Devices with ideally good know-how of IVD/Medical Devices Directives and Software Development.
• Possessing knowledge of design control requirements for In Vitro Diagnostic/Medical Devices (Software, instruments and analytical systems).
• Possessing solid working knowledge of the global regulations and standards applicable to medical device market clearance in regions including US, Canada, and EU.
• Being able to work as part of a team.
• Strong communication skills when working with customers, product stakeholders, notified bodies, and regulatory agencies.
• Strong critical thinking skills with attention to detail as well as ability to maintain visibility of the greater picture.
• Well organized and customer-focused.
• Self-starter, autonomous, reliable.

This is a fantastic opportunity to join a small but very dynamic company – do not wait any longer and take your next career step!