Regulatory Affairs Compliance Team Lead

3 weeks ago

Glasgow, United Kingdom FPSG Full time

**Regulatory Affairs Team Lead - Medical Devices**:
**Location: Glasgow, United Kingdom**:
FPSG is working with a leading medical device company dedicated to developing innovative solutions that improve patient outcomes. With a commitment to excellence and a passion for advancing healthcare, we are seeking a talented Regulatory Affairs Team Lead to join our dynamic team in Glasgow.

**Job Overview**:
As the Regulatory Affairs Team Lead, you will play a pivotal role in ensuring compliance with regulatory requirements for our range of medical devices. You will lead a team of regulatory professionals, providing guidance, expertise, and strategic direction to ensure successful product registrations, submissions, and compliance activities.

**Key Responsibilities**:

- Lead and manage the Regulatory Affairs team, providing mentorship, guidance, and professional development opportunities.
- Develop and implement regulatory strategies for new product submissions, including 510(k) filings, CE marking, and international registrations.
- Prepare, review, and submit regulatory documents to health authorities, ensuring accuracy, completeness, and compliance with relevant regulations.
- Serve as the primary point of contact for regulatory agencies, addressing inquiries, submissions, and audits.
- Collaborate cross-functionally with R&D, Quality Assurance, Clinical Affairs, and Marketing teams to support product development and launch activities.
- Stay updated on changes to regulatory requirements and industry standards, advising the organization on implications and strategies.
- Lead regulatory intelligence activities, conducting competitive assessments and monitoring regulatory trends.
- Participate in risk management activities, including hazard analysis, risk assessments, and mitigation strategies.
- Ensure compliance with ISO, FDA, EU MDR, and other applicable regulations, standards, and guidelines.

**Qualifications**:

- Bachelor's degree in a scientific or technical discipline; advanced degree (e.g., MSc, PhD) preferred.
- Minimum of 5 years of experience in regulatory affairs within the medical devices industry.
- Demonstrated experience leading regulatory submissions for medical devices (510(k), PMA, CE marking, etc.).
- Strong knowledge of FDA regulations (21 CFR), ISO 13485, and EU Medical Device Regulation (MDR).
- Proven leadership and team management skills, with a track record of developing high-performing teams.
- Excellent communication skills, with the ability to effectively collaborate across functions and influence stakeholders.
- Strategic thinker with the ability to analyze complex regulatory issues and develop innovative solutions.
- Detail-oriented with a commitment to quality and compliance.
- Regulatory affairs certifications (RAC) desirable.

  • Head of Regulatory Affairs

    3 weeks ago

    Glasgow, United Kingdom Mentholatum UK Ltd Full time

      Job title: Head of Regulatory Affairs Position reports to: Director of QA and RA Direct reports: RA Manager (UK, EEA, EAEU, CIS) RA Manager (Middle East) Compliance Manager Location:  East Kilbride/hybrid Employment status:  Full time, permanent Travel requirements:  Occasional domestic/international travel may be...

  • Head of Regulatory Affairs

    13 hours ago

    Glasgow, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory Affairs Position reports to: Director of QA and RA Direct reports: RA Manager (UK, EEA, EAEU, CIS) RA Manager (Middle East) Compliance Manager Location : East Kilbride/hybrid Employment status : Full time, permanent Travel requirements : Occasional domestic/international travel may be required. Other...

  • Head of Regulatory Affairs

    7 days ago

    Glasgow, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory Affairs Position reports to: Director of QA and RA Direct reports: RA Manager (UK, EEA, EAEU, CIS) RA Manager (Middle East) Compliance Manager Location : East Kilbride/hybrid Employment status : Full time, permanent Travel requirements : Occasional domestic/international travel may be required. Other special...

  • Head of Regulatory Affairs

    2 weeks ago

    Glasgow, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory Affairs Position reports to: Director of QA and RA Direct reports: RA Manager (UK, EEA, EAEU, CIS) RA Manager (Middle East) Compliance Manager Location : East Kilbride/hybrid Employment status : Full time, permanent Travel requirements : Occasional domestic/international travel may be required. Other special...

  • Regulatory Affairs

    1 day ago

    Glasgow, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory Affairs Position reports to: Director of QA and RA Direct reports: RA Manager (UK, EEA, EAEU, CIS) RA Manager (Middle East) Compliance Manager Location : East Kilbride/hybrid Employment status : Full time, permanent Travel requirements : Occasional domestic/international travel may be required. Other special...

  • Regulatory Affairs

    2 weeks ago

    Glasgow, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory Affairs Position reports to: Director of QA and RA Direct reports: RA Manager (UK, EEA, EAEU, CIS) RA Manager (Middle East) Compliance Manager Location : East Kilbride/hybrid Employment status : Full time, permanent Travel requirements : Occasional domestic/international travel may be required. Other special...

  • Head of Regulatory Affairs

    10 hours ago

    Glasgow, Glasgow City, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory AffairsPosition reports to: Director of QA and RADirect reports:RA Manager (UK, EEA, EAEU, CIS)RA Manager (Middle East)Compliance ManagerLocation: East Kilbride/hybridEmployment status: Full time, permanentTravel requirements: Occasional domestic/international travel may be required.Other special requirements: Some knowledge of...

  • Regulatory Affairs

    13 hours ago

    Glasgow, United Kingdom Mentholatum UK Ltd Full time

    Job title: Head of Regulatory Affairs Position reports to: Director of QA and RA Direct reports: RA Manager (UK, EEA, EAEU, CIS) RA Manager (Middle East) Compliance Manager Location : East Kilbride/hybrid Employment status : Full time, permanent Travel requirements : Occasional domestic/international travel may be required. Other special...

  • Principal- Regulatory Affairs

    1 month ago

    Glasgow, United Kingdom FPSG Full time

    **Regulatory Affairs Principal** **Overview** FPSG Life Sciences is delighted to be supporting our key client to recruit a Principal in their Regulatory Affairs team in Glasgow. Experience in medical devices or in Vitro diagnostics would be advantageous. Fantastic opportunity to be a part of a global business undergoing significant...

  • Head of Legal, Compliance

    17 hours ago

    Glasgow, United Kingdom Edrington Full time

    **Requisition Id**:1760**Location**:Glasgow, Scotland, GB, G1 3DNAbout Edrington Edrington’s vision is to give more by crafting exceptional ultra-premium spirit brands. The Macallan is our central focus, supported by Highland Park and The Glenrothes in the fast-growing single malt category and Naked Malt in the blended malt category. Our portfolio is...

  • Compliance Lead

    1 month ago

    Glasgow, United Kingdom Project People Full time

    **The Role**: The purpose of this role is to provide independent challenge, oversight and practical guidance to business areas with regards to the operation of its financial services products. You will sit in with financial services compliance team, and play a key role in the delivery of the monitoring plan and wider compliance programme. This will include...

  • Public Affairs Advisor

    4 weeks ago

    Glasgow, United Kingdom Statkraft Full time

    Public Affairs Advisor - Full-time **Company Description**: Statkraft is Europe's largest generator of renewable energy from hydro, wind and solar power. We have over 5,300 employees in 21 countries. We have been making clean energy possible for over 125 years, with unrivalled expertise in supplying the world with what it needs most. We envision a world...

  • Public Affairs Advisor

    4 weeks ago

    Glasgow, United Kingdom Statkraft Full time

    Company Description Statkraft is Europe's largest generator of renewable energy from hydro, wind and solar power. We have over 5,300 employees in 21 countries. We have been making clean energy possible for over 125 years, with unrivalled expertise in supplying the world with what it needs most. We envision a world that runs entirely on renewable...

  • Compliance Officer

    1 month ago

    Glasgow, United Kingdom Rawlplug Ltd Full time

    Job Summary: **Responsibilities**: - UKTAs (Technical Assessments) - Certificates of Conformance - Declarations of Conformance - Creation of a Technical File of all relevant documents - UKCA marking - Material Safety Data Sheets compliant with GB Regulations - Producer Responsibility Obligations (Packaging Waste) Regulations **Experience**: - HND/ Degree...

  • Associate Director, Promotional Materials

    1 week ago

    Glasgow, United Kingdom Scienta Full time

    About the Company:My client is an EU Leading Life Sciences Consultancy, with over 400% growth in the last 5 years, and have established themselves as a preferred partner for SME’s, Biotech’s, and Large Pharma alike, meaning plenty of growth opportunities for you should you join. They ensure to offer all employees great work-life balance and flexible...

  • Senior Compliance Officer

    1 month ago

    Glasgow, United Kingdom Verastar Limited Full time

    **The purpose of the role** As a Senior Compliance Officer, you will be responsible for ensuring the group complies with the regulatory requirements of the relevant regulator. The group’s regulators are Ofwat, Ofcom, WICS and Ofgem. You will be the first point of contact for the relevant regulator. **Responsibilities of the role** - Use regulatory...

  • Portfolio Compliance Analyst/ Investment Compliance

    2 weeks ago

    Glasgow, United Kingdom Eden Scott Full time

    Eden Scott’s client is seeking a highly motivated and detail-oriented Investment Compliance Analyst to join a financial services company based in Glasgow . As a key member of the Compliance team, you will work closely with the Compliance Manager to ensure adherence to regulatory requirements and promote a culture of compliance across the organisation. This...

  • Regulatory and Compliance Engineer

    1 week ago

    Glasgow, United Kingdom Carrington West Full time

    Job Title: Measurement and Technical Compliance Engineer (MTCE) My client are responsible for the auditing and monitoring of contractors for a busy road network in Scotland. They're looking for a Measurement and Technical Compliance Engineer to join the team based in Glasgow. Responsibilities of the Compliance Engineer: ·Carry out...

  • Lawyer - Regulatory

    9 hours ago

    Glasgow, United Kingdom DAC Beachcroft LLP Full time

    Or an environment where you can enjoy industry-leading work quality without compromising on client contact and business development? An opportunity in our Regulatory SHE team may be for you. Our market leading Regulatory Team are specialists in Safety, Health and Environment (SHE) work. The work includes advising insurers' policyholders and corporate...

  • Compliance Consultant

    1 month ago

    Glasgow, United Kingdom Meraki Full time

    Meraki Talent’s industry leading Life & Pensions client are looking for a Compliance Consultant. This role sits within the Compliance 'second line of defence' function - this function is key in helping the wider risk/compliance team and Board to understand how regulatory and conduct risks are being managed across the entire business. This is your chance...