Regulatory Affairs Senior Specialist

<p paraeid="{c749c7f8-02f1-4e86-a70e-f087d9ec4b01}{130}" paraid="88454778">#LI-onsite</p><p paraeid="{c749c7f8-02f1-4e86-a70e-f087d9ec4b01}{164}" paraid="699772726"><span><span> </span></span></p><p paraeid="{4426bc5d-5bd6-4f17-8643-d403b24fd2c8}{21}" paraid="1007800682"><span><span lang="EN-US" xml:lang="EN-US">At CooperSurgical, we are currently looking to recruit a Regulatory Affairs Specialist to join our Global Regulatory Affairs team. This role focuses primarily on the US (FDA), Canada (Health Canada) and Australia (TGA) markets, ensuring compliance and supporting submissions that enable patients and healthcare professionals to access our innovative fertility and women’s health solutions worldwide.</span><span> </span></span></p><p paraeid="{c749c7f8-02f1-4e86-a70e-f087d9ec4b01}{208}" paraid="2053231919"><span><span lang="EN-US" xml:lang="EN-US">You will report to the Regulatory Affairs Manager based in Denmark/Spain and collaborate closely with colleagues across RA, QA, R&amp;D, Supply Chain, and commercial </span><span lang="EN-US" xml:lang="EN-US">teams.</span><span> </span></span></p><p paraeid="{6f1f07c1-d754-49a1-86ba-ccf2bbf7a416}{33}" paraid="1817451700"> </p><p paraeid="{6f1f07c1-d754-49a1-86ba-ccf2bbf7a416}{33}" paraid="1817451700">Location: Copenhagen Denmark or Barcelona Spain</p><p paraeid="{6f1f07c1-d754-49a1-86ba-ccf2bbf7a416}{33}" paraid="1817451700">Workplace: Onsite</p><p paraeid="{6f1f07c1-d754-49a1-86ba-ccf2bbf7a416}{33}" paraid="1817451700"> </p><p paraeid="{6f1f07c1-d754-49a1-86ba-ccf2bbf7a416}{33}" paraid="1817451700"><span><span lang="EN-US" xml:lang="EN-US"><strong>The Role</strong></span><span> </span></span></p><p paraeid="{6f1f07c1-d754-49a1-86ba-ccf2bbf7a416}{39}" paraid="1910382911"> </p><p paraeid="{6f1f07c1-d754-49a1-86ba-ccf2bbf7a416}{39}" paraid="1910382911"><span><span lang="EN-US" xml:lang="EN-US">As Regulatory Affairs Specialist, you will take ownership of regulatory activities in the US, Canadian, and Australian markets. This includes regulatory submissions, renewals, license notifications, and product change assessments (letters-to-file / not-to-file). You will also contribute to 510(k) submissions, ensuring documentation is accurate, compliant, and delivered on time.</span><span> </span></span></p><p paraeid="{b0a6f884-a35e-48e0-a6b6-dcfe52e63e3b}{145}" paraid="100007817"><span><span lang="EN-US" xml:lang="EN-US">This is a dynamic position where you will balance regulatory rigor with proactive planning. You will thrive if you enjoy driving projects forward, working with cross-functional stakeholders, and keeping a structured overview in a busy, fast-moving environment. </span><span> </span></span></p><p paraeid="{c749c7f8-02f1-4e86-a70e-f087d9ec4b01}{254}" paraid="2051498711"><span><span lang="EN-US" xml:lang="EN-US">The position as RA Specialist is vital for the success and growth of CooperSurgical.</span><span> </span></span></p><p paraeid="{a4cae5c7-bb01-4abc-afa0-2df5c4fe0b59}{101}" paraid="952915705"> </p><p paraeid="{a4cae5c7-bb01-4abc-afa0-2df5c4fe0b59}{101}" paraid="952915705"> </p><p paraeid="{a4cae5c7-bb01-4abc-afa0-2df5c4fe0b59}{101}" paraid="952915705"><span><span lang="EN-US" xml:lang="EN-US"><strong>Key Responsibilities</strong></span><span> </span></span></p><ul role="list"><li aria-setsize="-1" role="listitem"><p paraeid="{a4cae5c7-bb01-4abc-afa0-2df5c4fe0b59}{107}" paraid="305226932"> </p></li><li aria-setsize="-1" role="listitem"><p paraeid="{a4cae5c7-bb01-4abc-afa0-2df5c4fe0b59}{107}" paraid="305226932"><span><span lang="EN-US" xml:lang="EN-US">Lead regulatory activities for US, Canada and Australia. Preparing, submitting, and maintaining files and legalized documentation.</span><span> </span></span></p></li></ul><ul role="list"><li aria-setsize="-1" role="listitem"><p paraeid="{a4cae5c7-bb01-4abc-afa0-2df5c4fe0b59}{113}" paraid="200344446"><span><span lang="EN-US" xml:lang="EN-US">Perform regulatory assessments of product changes, including letter-to-file / not-to-file decisions.</span><span> </span></span></p></li></ul><ul role="list"><li aria-setsize="-1" role="listitem"><p paraeid="{a4cae5c7-bb01-4abc-afa0-2df5c4fe0b59}{119}" paraid="941601227"><span><span lang="EN-US" xml:lang="EN-US">Manage annual renewals, license maintenance, and regulatory notifications.</span><span> </span></span></p></li></ul><ul role="list"><li aria-setsize="-1" role="listitem"><p paraeid="{a4cae5c7-bb01-4abc-afa0-2df5c4fe0b59}{125}" paraid="854891354"><span><span lang="EN-US" xml:lang="EN-US">Support the preparation of 510(k) submissions and updates to technical documentation.</span><span> </span></span></p></li></ul><ul role="list"><li aria-setsize="-1" role="listitem"><p paraeid="{a4cae5c7-bb01-4abc-afa0-2df5c4fe0b59}{131}" paraid="1828235016"><span><span lang="EN-US" xml:lang="EN-US">Coordinate collection and review of data for international registrations.</span><span> </span></span></p></li></ul><ul role="list"><li aria-setsize="-1" role="listitem"><p paraeid=