Job Description:
You will be responsible for global regulatory submissions, annual reporting to notified bodies and competent authorities, and maintaining compliance to standards and regulations.
This position requires a highly motivated self-starter with a willingness to contribute to regulatory compliance enhancements. Strong organisational skills, ability to balance immediate vs. long term priorities, and multi-tasking skills are essential.
An ability to work in a flexible entrepreneurial environment is necessary.
* Support day-to-day regulatory activities as well as handle multiple projects related to regulatory compliance.
* Assist in the implementation of MDSAP within the organisation.
* Support the team to obtain/retain country-specific regulatory registrations globally.
* Work with the commercial team/distributors to ensure country specific registration activities are understood and addressed.
* Work closely with interdisciplinary team members to ensure the effectiveness of the QMS to regulations.
* Work closely with QA for internal and external audits, including notified body audits as required.
* Support the team to ensure product manufacture and testing meets CE mark and FDA submission requirements.
* Work with suppliers to ensure products' process validations and risk management files meet regulatory submission standards.
* Provide strategic regulatory insight to team members on product development plans.
* Maintain post-market surveillance activities including logging customer complaints and adverse events, coordinating investigations between complainants and contract manufacturing sites, addressing initiatives to test/change/improve products as required by regulations, and regulatory trending/reporting activities.
* Monitor global regulatory trends and requirements impacting product development and commercialization and advise colleagues/partners on compliance.
* Evaluate manufacturing and labelling changes/promotional materials for regulatory impact and ensure compliance with applicable regulations.
* Maintain awareness of global regulatory legislation and assess its impact on business and product development programs.
* Keep up to date with domestic/international regulations and guidelines and advise key staff on compliance/non-compliance with current international regulations/policies and EC directives.
* Support the team with CE mark submissions, significant change notifications, and Notified Body interactions.
* Support the team with international regulatory filings including 510(k) submissions and subsequent FDA correspondence.
Required Skills and Qualifications:
* Bachelor's degree in Engineering or Science with a minimum of 3 years of regulatory experience in the medical device industry.
* Regulatory certifications in EU MDR and US FDA desirable.
* Thorough understanding/knowledge of ISO 13485, ISO 14971, EU MDR, UK MDR, MDSAP, US 21 CFR 820, and supporting standards.
* Proven track record with the ability to successfully manage projects to deadlines.
* Experience working directly with regulatory agencies.
* Strong ability to manage critical projects as part of an interdisciplinary team.
* Excellent problem-solving and communication skills.
* Self-motivated, highly organised, and detail-oriented.
* Excellent oral/written communication skills.
* Able to work as part of a cross-functional team.
* Fits well in a fast-paced/entrepreneurial environment.
Benefits:
We offer an excellent package for the right candidate.