Regulatory Affairs Manager

Working at Freudenberg: We will wow your world!

Responsibilities:

• Provide regulatory excellence to the organization and guide decision making in cross-functional settings as a player/ coach

• Creates and oversees regulatory plans and submissions as well as associated documents for FDA, Health Canada, MDR Notified Bodies, and ROW countries to secure approvals, e.g. 510(k), EU Technical Files

• Responsible to direct, coordinate and supervise activities of the Regulatory Affairs team. Establish project priorities, ensure resources are available and balanced

• Regulatory lead for cross-functional project teams (new product development, commercial, manufacturing, obsolescence, new suppliers, etc.) providing regulatory input and guidance

• Maintains company registration and device listings for global regulatory bodies, e.g. FDA Establishment Registration, FDA Device Listings, FDA Certificates to Foreign Government

• Responsible for completion of international product registrations and providing regulatory information to distributors

• Regulatory review and approval of product labeling, marketing and advertising copy

• Regulatory assessment, input and approval of product development and design control projects

• Responsible for ensuring that the company is aware of and properly references appropriate and relevant medical device standards, regulations, and directives and provides interpretive assistance for new filings

• Responsible for regulatory reporting, such as FDA Medical Device (MDR), CMDR and EU Vigilance assessment and reporting to domestic and international agencies

• Responsible to internally organize and complete domestic and international recall issues; communicate recall actions to domestic and international agencies and distributors

• Works in conjunction with local and divisional management to ensure that company and quality system are compliant with all federal, state, local and company specific regulations as they apply to medical devices or a medical device facility; responsible for ensuring that Notified Body/MDSAP/regulatory audits are performed per current regulatory guidelines/procedures

• This position is the Freudenberg Medical “Person Responsible for Regulatory Compliance” (PRRC) per the EU MDR (2017/745), Art. 15. This position is responsible as the PRRC in regards to ensuring that:

  • the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

  • the post-market surveillance obligations are complied with in accordance with Article 10(10);

  • the reporting obligations referred to in Articles 87 to 91 are fulfilled;

  • in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

• Reviews & performs regulatory impact assessments for manufacturing and product changes for notification to regulatory bodies

• Conducts training programs to educate employees on regulatory processes and requirements

• Communicates with regulatory authorities regarding clarification of and follow-up of submissions under review

• Assesses product, manufacturing and labeling changes for regulatory reporting and reviews marketing and sales materials for compliance to regulations

• Regulatory liaison/ representative for internal and external audits

Qualifications:

• BS degree (preferably in Regulatory Sciences/ Practices, etc.) or equivalent certification with RA coursework/ seminars

• Must have a minimum of 8 years regulatory experience with medical devices with a track record of successful submissions to FDA and MDR

• Experience preparing & defending regulatory submissions to the FDA (510(k), Qsubs, IDE’s, MDR technical files

• Proven experience and success in dealings with Notified Bodies, Competent Authorities, Authorized Representatives

• Willingness and ability to travel to Carpinteria, CA, per business need

• Strong knowledge and expertise of global regulatory requirements

• Thorough knowledge of FDA medical device regulations

• Thorough knowledge of ISO quality system and CE medical device standards, guidelines and directives

• Managerial experience supervising direct reports, strong leader to support and develop teams and colleagues

• Player/ coach who gets things done and performs well in a dynamic environment

• Independence and self-direction coupled with a strong desire to work collaboratively as part of a high-performing cross-functional team

• Outstanding written and verbal communication skills

• Keen ability to prioritize work and execute in an environment of competing priorities

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.