Regulatory

Regulatory

At any time, there are more than300,000 clinical studieshappening around the world. The process for bringing new pharmaceuticals to the market is prolonged due to regulation placed on the drugs sector in order to protect public safety.The Federal Institute for Drugs and Medical Devices(Bundesinstitut fรผr Arzneimittel und Medizinprodukte or BfArM) is the legal narcotics and medical device regulatory authority in Germany. According to the BfArM, โ€œThey are involved in the tasks of licensing, improving the safety of medicinal products, detecting and evaluating the risks of medical devices, and monitoring the legal traffic in narcotic drugs and precursors.โ€

The effects of Brexit are being felt across many different industries in Germany, particularly in the pharma regulatory sector. The BfArM is one of the major licensing authorities in the EU and actively supports theEuropean Medicines Agencyin all key areas of drug authorisation and drug safety, together with thePaul Ehrlich institute, more than480 experts bring their expertise to around 130 scientific bodiesof the EMA.

According toProf. Dr Karl Broich, President of the BfArM, โ€œThe organisation makes significant contributions to the supply of patients in Europe with safe medications and will increase these contributions in the years to come after Brexit and the loss of the British licensing authority, the number of authorisation processes will also increase, for Germany in particular.โ€

Increased demand for regulation following Brexit will likely see substantial growth in the market over the next number of years. At the moment theBfArM employs roughly 1,100 employeesacross many different specialisms including physicians, pharmacists, chemists, biologists, lawyers, engineers, technical assistants, administrative staff. More than 130 of their nearly 1,100 employees will reach the age of 65 within the next 5 years, in other words, 12 % of the staff will retire in the near future. This will free up numerous jobs that will need to be filled as Europe becomes more reliant on Germany to spearhead regulation following the UKโ€™s exit of the EU.

EPM Scientific is a global specialist recruitment company working exclusively in the Life Sciences industry. Our expert consultants place talent in the regulatory industry in Germany and across Europe.

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We have over a decadeโ€™s worth of experience as a leading talent partner in Life Sciences & Pharma.

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A vast, global network of the best, in-demand professionals, working with the worldโ€™s largest Life Sciences institutions, to take drugs, devices and therapeutic applications through from conception to completion.

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Regulatory Jobs

Regulatory Affairs Manager

Title: Regulatory Affairs Manager Location: San Jose, CA Base Salary: $140,000-$190,000 About: Currently working with a medical device company dedicated to developing and commercializing breakthrough catheter devices that revolutionize patient care on a Regulatory Manager position. In this critical role, you will play a pivotal role in ensuring our breakthrough catheter devices navigate the regulatory pathway efficiently and successfully. You will be responsible for developing and implementing regulatory strategies to obtain market authorization from the FDA, including 510(k) clearances and PMAs. Responsibilities: Lead the regulatory strategy for our catheter device portfolio, with a particular focus on breakthrough devices. Manage the preparation and submission of regulatory filings, including 510(k) premarket notifications and PMA applications, ensuring compliance with FDA requirements. Oversee communication and interaction with the FDA throughout the regulatory process. Interface with cross-functional teams (R&D, Quality, Clinical) to gather necessary regulatory data and documentation. Develop and maintain a comprehensive understanding of relevant FDA regulations and guidance documents for catheter devices. Stay abreast of regulatory trends and proactively identify potential risks and opportunities. Manage and mentor junior members of the Regulatory Affairs team. Qualifications: Minimum of 5 years of experience in medical device regulatory affairs with a focus on catheters. Proven track record of successfully obtaining 510(k) clearances and/or PMAs for medical devices. In-depth knowledge of FDA regulations (21 CFR 801, 820, etc.) and guidance documents for catheter devices. Strong understanding of the regulatory pathway for breakthrough devices. Excellent project management, communication, and interpersonal skills. Ability to work independently and as part of a cross-functional team. Meticulous attention to detail and a strong commitment to quality.

Negotiable
California
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Senior Director Regulatory Affairs

Summary: Our client, a clinical stage biopharmaceutical company based in California, is seeking an experienced and highly motivated, hands-on regulatory affairs leader to join their team. The successful candidate will be responsible for developing and implementing effective regulatory strategies to support the development of innovative cell therapies. Responsibilities: Serve as the primary liaison with company executives and external company partners. Lead interactions with global health authorities. Collaborate cross-functionally with team members. Oversee submissions including IND/CTA, BLA, Orphan drug designations and amendments Provide expert guidance to the company on all Regulatory matters Skills/Requirements: 10 + years of regulatory affairs experience Extensive experience with Biologics Cell Therapy experience Clinical regulatory experience required. Ability to develop comprehensive global regulatory strategy Successful track record working collaboratively across functions Understanding of CMC related functions Oncology experience preferred

Negotiable
California
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Regulatory Affairs Manager

As a Regulatory Affairs Manager (m/f/d) you'll take ownership of all Regulatory topics in a very critical role to the company's future and help to fulfil relevant national and international regulatory requirements. A great opportunity to join a leading Medical Device company in Germany with a great portfolio of products . Responsibilities RA support during the whole product life cycle (development, certification / registration/ marketing material/post market surveillance) Establish and update processes in your area of responsibility for staying in compliance in a changing regulatory environment, including environmental regulations (Reach, RoHSโ€ฆ) Lead/support communication (registration/reporting) with authorities/regulatory agencies/designated bodies (EU and worldwide) and manage international audit/inspection programs as required Coordinate, manage and implement regulatory strategies for new and established products Lead/support efforts to register and launch new products Lead/support post market surveillance activities from a regulatory perspective Lead/support CAPA activities from a regulatory perspective Mentor/coach/advise on IVD/MD related processes within the organisation Supporting NRTL certification, Factory Inspection Does this sound interesting to you? Qualifications Diplom/ Master's degree in medical technologies, engineering, natural sciences Optional: Advanced training, additional qualifications Market Surveillance (PMS & Vigilance) Usability and Software Life Cycle processes conformity assessment of IVD/MD products, registrations in key markets (CE, US, China) Minimum 5 years of experience in Quality and/or Regulatory Affairs for medical products or related areas with comprehensive knowledge of regulations for IVDs, (instruments, software, reagents), focus: CE-countries, US Knowledge in Post-Market-Surveillance Activities of IVD / medical devices Knowledge of ISO 14971 Risk Assessment Activities and Risk Management of medical devices Basic Experience with IEC/EN 62304 and IEC/EN 62366 Basic Knowledge of IEC/EN 61010 (preferred) or IEC/EN 6060 Fluent in English and German

Negotiable
Karlsruhe
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Head of Regulatory Affairs

Head of Regulatory Affairs (m / f / d) Combination Products As a Head of Regulatory Affairs (m/f/d) you'll take ownership of all Regulatory topics in a very critical role to the company's future and help to fulfil relevant national and international regulatory requirements. A great opportunity to join a leading Medical Device company in Germany with a great portfolio of products . Your Responsibilities Will Include, But Are Not Limited To: Coordination and implementation of the approval of our products for international markets Creation of regulatory strategies and plans for worldwide approvals Independent preparation of the submission documentation for the global approval of medical devices Creation of all required registration documents and procurement of the necessary certifications in exchange with external interfaces Preparation, organisation and support of audits by notified bodies and authorities Contact person (m / f / d) for regulatory issues continuously drive the optimisation of global, cross-location regulatory affairs processes Key Requirements: Bachelor of Science degree in engineering or a scientific/technical discipline A minimum of 7 years related experience in the medical device industry in Regulatory Affairs, with at least 3 years of experience in leadership Knowledge of the normative and regulatory requirements for medical devices (ISO 13485: 2016, ISO 14971: 2019, Directive 93/42 / EEC and Regulation (EU) 2017/745 (MDR) and FDA Experience working with drug-delivery products and combination products Support with international registrations Knowledge and experience with Software as a Medical Devices (SamD) Demonstrated ability to work constructively across all functions of the organisation Very good written and spoken German and English

Negotiable
Olten
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Team Lead Regulatory Affairs

As a Team Lead Regulatory Affairs (m/f/d) you'll take ownership of all Regulatory topics in a very critical role to the company's future and help to fulfil relevant national and international regulatory requirements. A great opportunity to join a leading Medical Device company in Germany with a great portfolio of products . Your Responsibilities Will Include, But Are Not Limited To: Coordination and implementation of the approval of our products for international markets Creation of regulatory strategies and plans for worldwide approvals Independent preparation of the submission documentation for the global approval of medical devices Creation of all required registration documents and procurement of the necessary certifications in exchange with external interfaces Preparation, organisation and support of audits by notified bodies and authorities Contact person (m / f / d) for regulatory issues continuously drive the optimisation of global, cross-location regulatory affairs processes Key Requirements: Bachelor of Science degree in engineering or a scientific/technical discipline A minimum of 5 years related experience in the medical device industry, with at least 3 years of experience in Regulatory Affairs Knowledge of the normative and regulatory requirements for medical devices (ISO 13485: 2016, ISO 14971: 2019, Directive 93/42 / EEC and Regulation (EU) 2017/745 (MDR) Support with international registrations Demonstrated ability to work constructively across all functions of the organisation Very good written and spoken French and English If you are interested in the role, apply online today.

Negotiable
Berlin
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Regulatory Affairs Manager

The company offers a unique opportunity to combine scientific excellence with commercial success in a future-oriented environment, with innovation and team spirit at its core. A family-friendly company policy, flexible working time models, a wide range of further training opportunities and company health management round off the offer. Your qualification You have completed a technical or scientific degree or comparable training You have initial experience in the area of regulatory affairs as well as knowledge of national and international approval procedures. You are characterised by a strong service orientation combined with a pleasant, communicative and a structured and reliable way of working. Good knowledge of relevant regulations and standards, including Regulation (EU) 2017/745 (MDR), Directive 93/42/EEC (MDD), 21 CFR 820, ISO 13485 as well as initial experience in technical documentation and clinical evaluation are required. Very good spoken and written knowledge of German and English as well as very good knowledge of MS Office complete your profile. Your tasks Ensuring compliance with all relevant national and international requirements for the products. Responsibility for product approval in specified countries and regular review of existing approvals as well as support of product development from a regulatory perspective. Responsible for the creation and maintenance of clinical assessments for medical devices and the creation of technical documentation for medical devices. Maintaining communication with authorities, certification bodies and external partners to obtain and maintain approvals and certificates of conformity. Work closely with internal teams such as development, product management and quality management to ensure product conformance to required standards.

Negotiable
Baden-Wรผrttemberg
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Senior Regulatory Affairs Manager - Clinical trial

We are currently seeking a talented and experienced Senior Regulatory Affairs Manager to join our client's team in Surrey. Our client is an established cosmetics/pharmaceuticals company looking for someone with expertise in global cosmetic regulations. In collaboration with a highly skilled international team you will help to manage the clinical trial applications in Europe and other selected countries. Responsibilities: As the Regulatory Affairs Associate at our client's organisation, your primary responsibilities will include but not limited to: Regulatory: Contribute to ongoing global regulatory strategy development Handle marketing authorisation submissions, variations, and responses to regulatory queries Clinical trial applications: Prepare and compile documentation for clinical trial applications in Europe and other selected countries Submit applications to competent authorities and ethics committees Manage labelling, obtain approvals, and handle amendments for clinical trials Pricing & Reimbursement: Handle marketing authorization applications Manage life cycle of approved products Qualifications & Skills Required: The ideal candidate should have the following qualifications/skills: Experience in the preparation of clinical trial applications is essential Post-graduate qualifications in Pharmacy, Biological Sciences, or related disciplines. Pharmaceutical industry experience Our client offers a highly competitive salary with benefits, hybrid flexibility, impressive career progression opportunities and a chance to work alongside world-leading scientific experts. Apply now for a chance to work for fast growing company who is directly benefiting health care and changing lives!

ยฃ60000 - ยฃ60001 per annum
England
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RA Project Manager - Cosmetics

We are currently seeking a talented and experienced Regulatory Affairs Project Manager to join our client's team in Surrey. Our client is an established cosmetics/pharmaceuticals company looking for someone with expertise in global cosmetic regulations. In collaboration with a highly skilled international team you will support in the provision of general regulatory advice on global cosmetic regulations. Responsibilities: As the RA Project Manager at our client's organisation, your primary responsibilities will include but not limited to: Development of effective strategies that comply with local and international requirements Managing project time lines while ensuring adherence to set guidelines Product life cycle and portfolio management Provision of regulatory training Support clinical staff in the design of adequate studies and gain study approval Qualifications & Skills Required: The ideal candidate should have the following qualifications/skills; At minimum of 3 years experience working within the pharmaceutical or cosmetics industry. A minimum of 2 year's experience as a Regulatory Affairs professional. Bachelor's Degree in a scientific/technical/engineering discipline or equivalent required Proven cosmetic product registration experience Global Cosmetic regulatory knowledge Our client offers a highly competitive salary with benefits, hybrid flexibility, impressive career progression opportunities and a chance to work alongside world-leading scientific experts. Apply now for a chance to work for fast growing company who is directly benefiting health care and changing lives!

Negotiable
England
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